Associated tags: Spine, Biotie Therapies, Medical device, FDA, Health, Food, Tiber, MDR, Trauma
Locations: PENNSYLVANIA, TIBER, US, CANADA
Retrieved on:
Monday, February 12, 2024
BETHLEHEM, Pa., Feb. 12, 2024 /PRNewswire/ -- Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, has received a U.S. Food and Drug Administration (FDA) 510(k) approval for its Proximal Tibia Plating System. The Tyber Medical System consists of two indication categories: Complete Articular and Partial Articular Fractures. Both designs stabilize bone fragments to facilitate highly focused and efficient healing of a wide array of injuries to the tibia, fibula, and femur. "This innovative addition to the Tyber Medical portfolio aligns to meet the needs of our customers by offering multiple solutions to challenging anatomy," commented David Hannah, Chief Technology Officer at Tyber Medical. Mr. Hannah added. "This comprehensive system offers anatomic plating to support a wide range of trauma needs."
Key Points:
- BETHLEHEM, Pa., Feb. 12, 2024 /PRNewswire/ -- Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, has received a U.S. Food and Drug Administration (FDA) 510(k) approval for its Proximal Tibia Plating System.
- The Tyber Medical System consists of two indication categories: Complete Articular and Partial Articular Fractures.
- The Tyber Medical Proximal Tibial Plating System is engineered to accommodate surgeon preferences, increase procedural efficiency, and enhance plate fit and screw placement.
- Lisa Boyle, Director of Regulatory Affairs commented "With the clearance of the Proximal Tibial Plating System and its sub-categories, Tyber Medical remains unwavering in our commitment to providing cutting edge orthopedic solutions."
Retrieved on:
Tuesday, February 6, 2024
Deformity,
MDR,
Titanium,
Stainless steel,
Engineering,
FDA,
Trauma,
Health Canada,
Health,
Fatigue,
Medical device BETHLEHEM, Pa., Feb. 6, 2024 /PRNewswire/ -- Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, received clearance for the anatomical plating system in Canada. The comprehensive portfolio previously received FDA 510(k) in the US and has now been cleared through Health Canada.
Key Points:
- BETHLEHEM, Pa., Feb. 6, 2024 /PRNewswire/ -- Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, received clearance for the anatomical plating system in Canada.
- Tyber Medical's CEO and President, Jeff Tyber, announced that the company has received clearance from Health Canada to offer a comprehensive plating solution for long and short bone trauma and deformity.
- "We are excited about this development and look forward to expanding our presence in the orthopedic plating arena," said Tyber.
- Chief Commercial Officer Kevin Brothen said, "This additional clearance for Canada further cements Tyber Medical as a complete global source for orthopedic plating and we are excited for the future."
Nonunion,
Titanium,
Hand,
Trauma,
Wrist,
Fracture,
Food and Drug Administration,
Foot,
Ankle,
Growth,
Food,
Anatomy,
FDA,
Surgeon,
Medical device BETHLEHEM, Pa., Jan. 29, 2024 /PRNewswire/ -- Tyber Medical, LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity and spine markets, has received a U.S. Food and Drug Administration (FDA) 510(k) approval for a line extension to the existing, approved Mini-Frag System, with additional screw and plate options, and indications. This additional clearance expands Tyber Medical products' healing capabilities and adds to their restorative portfolio.
Key Points:
- This additional clearance expands Tyber Medical products' healing capabilities and adds to their restorative portfolio.
- The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, nonunions and fusions in the hand, wrist, foot and ankle.
- The Anatomical Plating System provides versatility, precision and efficiency in one system, and is offered in both titanium and stainless-steel.
- The line extension to the Mini-Frag System includes 1.3mm screws and plates, expanding the range of sizes in the Tyber Medical Mini-Frag System.
Retrieved on:
Monday, December 18, 2023
Food and Drug Administration,
Food,
Malunion,
Ulna,
FDA,
Radius,
Fracture,
Hand,
Trauma,
Stainless steel,
Titanium,
Orientation BETHLEHEM, Pa., Dec. 18, 2023 /PRNewswire/ -- Tyber Medical, LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, received a U.S. Food and Drug Administration (FDA) 510(k) clearance for its new Distal Radius Plating System. Tyber Medical's novel design covers a wide range of fractures, fusions, non-unions, malunions, or osteotomies of the radius, ulna, and hand. "The Tyber Medical Distal Radius System provides an innovative approach to address one of the most common fractures. Additionally, the enhanced ergonomic design delivers a solution to reduce flexor tendon irritation, a common post operative concern," said Tyber Medical CEO and President Jeff Tyber.
Key Points:
- Tyber Medical Expands Its Extensive Plating Portfolio with FDA Approval of Distal Radius Plating System for Fractured Radius, Ulna and Hand Bones
BETHLEHEM, Pa., Dec. 18, 2023 /PRNewswire/ -- Tyber Medical, LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, received a U.S. Food and Drug Administration (FDA) 510(k) clearance for its new Distal Radius Plating System.
- Tyber Medical's novel design covers a wide range of fractures, fusions, non-unions, malunions, or osteotomies of the radius, ulna, and hand.
- "The Tyber Medical Distal Radius System provides an innovative approach to address one of the most common fractures.
- Tyber Medical's Distal Radius Plating System maintains stability and orientation in the anteroposterior plane utilizing a dynamic grouping of plate length options, offered in titanium or stainless steel.
Retrieved on:
Tuesday, November 28, 2023
Safety,
Policy,
Creativity,
Labour,
Independent safety officer,
GOSH,
Conference,
Human,
Trauma,
Occupational safety and health,
Environment,
Trade and Industry Department,
Work Hard, Play Hard,
Workplace,
Nursing,
Management,
Culture,
Health BETHLEHEM, Pa., Nov. 28, 2023 /PRNewswire/ -- Tyber Medical has been selected to receive the Governor's Award for Safety Excellence (GASE)—a highly competitive program that acknowledges exceptional safety and prevention initiatives in the workplace as well as the effective and successful management of those initiatives by its employees.
Key Points:
- BETHLEHEM, Pa., Nov. 28, 2023 /PRNewswire/ -- Tyber Medical has been selected to receive the Governor's Award for Safety Excellence (GASE)—a highly competitive program that acknowledges exceptional safety and prevention initiatives in the workplace as well as the effective and successful management of those initiatives by its employees.
- In order for our team to make these great products, the company needs to provide a safe, efficient workplace that keeps our "Work Hard, Play Hard" mentality on track," said Jeff Tyber, CEO and President of Tyber Medical.
- "The GASE award is an acknowledgment of that mentality as well as our commitment to maintaining an industry-leading approach to safety and performance."
- Tyber Medical was presented the award by representatives of the Department of Labor & Industry at the Governor's Occupational Safety and Health (GOSH) Conference this past October, and the safety practices used at the Tyber Medical facilities are now shared state-wide as a model to reference for businesses within the industry.
Retrieved on:
Thursday, September 21, 2023
Diamond,
ADSM,
Wire,
Tiber,
SAE 316L stainless steel,
ELI,
Stainless steel,
MDR,
Acquisition,
Patient,
Sterility,
FDA,
Health,
Medical device,
Pharmaceutical industry,
Titanium BETHLEHEM, Pa., Sept. 21, 2023 /PRNewswire/ -- Tyber Medical, a leader in the medical device industry, is pleased to announce that it has received:
Key Points:
- BETHLEHEM, Pa., Sept. 21, 2023 /PRNewswire/ -- Tyber Medical, a leader in the medical device industry, is pleased to announce that it has received:
FDA and MDR clearance for its implantable K-Wires and Steinmann Pins made from 316L Stainless Steel and Titanium alloy Ti6AL4V ELI.
- "Our focus has always been on developing products that are innovative, efficient, and deliver unparalleled performance," said Jeff Tyber, CEO of Tyber Medical.
- "Receiving the FDA and MDR clearance for these platforms is a testament to our rigorous pursuit of advancing patient care while helping our customers expand their brand."
- Tyber Medical continues to innovate and push boundaries in the medical device industry, constantly striving to provide cutting-edge solutions that redefine patient care.
The expansion will effectively double the size of its operations in Florida, adding new manufacturing machines, secondary equipment, and additional new technologies.
Key Points:
- The expansion will effectively double the size of its operations in Florida, adding new manufacturing machines, secondary equipment, and additional new technologies.
- This move comes as part of Tyber Medical's $13 million plus capital asset expansion plan over the next two years.
- This expansion is good for Tyber Medical's employees' career development, its key stakeholders, and of course its growing customer base."
- With this expansion, Tyber Medical will be able to support progressively larger product launches, as the company continues its heavy expansion into plating and screw technology.
Health,
Ankle,
Foot,
Trauma,
Environment,
Anatomy,
ASTM,
Spine,
Wrist,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
MRI,
Hand,
Food,
FDA,
Safety,
Deformity,
Medical device,
Medical imaging BETHLEHEM, Pa., March 9, 2023 /PRNewswire/ -- Tyber Medical LLC, the global leader in private-label medical devices for major orthopedic trauma, extremity and spine companies, has been granted a 510(k) clearance by the U.S. Food and Drug Administration to expand its anatomical plate portfolio and an additional clearance for MR Conditional labeling. The company's latest FDA clearance extends the breath of its Anatomical Plating System with 391 additional plate configurations, including 100 new plates targeting foot, ankle and wrist indications.
Key Points:
- The company's latest FDA clearance extends the breath of its Anatomical Plating System with 391 additional plate configurations, including 100 new plates targeting foot, ankle and wrist indications.
- Tyber Medical's Anatomical Plating System was also deemed safe to carry MR Conditional labeling by the FDA.
- The MR Conditional term allows Tyber Medical's Anatomical Plating System to be safely used in the MRI environment under certain tested conditions.
- Tyber Medical officially launched its Anatomical Plating System in 2020, when the product line received its initial 510(k) clearance from the FDA.
Retrieved on:
Wednesday, January 25, 2023
Marketing,
CFO,
Orthopedic surgery,
Globus Medical,
OEM,
Financial management,
NuVasive,
Tap,
Area,
Chief commercial officer,
Management,
Trauma BETHLEHEM, Pa., Jan. 25, 2023 /PRNewswire/ -- To further accelerate record growth and rapid commercialization through its OEM partnerships with leading orthopedic companies in the global trauma, extremity and spine markets, Tyber Medical LLC has tapped industry veteran James Abraham for its newly-created Chief Commercial Officer role and Damien Sibilla for the role of Chief Financial Officer. Both are serving on Tyber Medical's executive leadership team.
Key Points:
- Both are serving on Tyber Medical's executive leadership team.
- Abraham and Sibilla will lead Tyber Medical's expansion through OEM partnerships at leading orthopedic companies.
- We are thrilled to have Jim on board to take our product commercialization to the next level," said Tyber Medical Chief Executive Officer, Jeff Tyber.
- "We are very excited to have Damien join our executive leadership team," said Tyber.
Retrieved on:
Tuesday, November 15, 2022
Health,
Food and Drug Administration,
MDR,
Gaps,
Compliance,
Physician,
Surgeon,
FDA,
Nickel titanium,
Two shot,
Spine,
Multimedia,
Fracture,
Osteotomy,
Engineering,
Food,
Medical device,
Dentistry BETHLEHEM, Pa., Nov. 15, 2022 /PRNewswire/ -- Tyber Medical LLC, the global, leading private-label medical device provider for major orthopedic trauma, extremity, and spine companies, has been awarded a U.S. Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot™ Staple Fixation System. The NiTy+ One-Shot is the first instrument of its kind in the bone-fixation device market to feature a uniquely designed, single-pass insertion instrument. Designed with surgical efficiency in mind, the NiTy+ One-Shot is particularly beneficial in the case of fracture, osteotomy fixation, and joint arthrodesis.
Key Points:
- BETHLEHEM, Pa., Nov. 15, 2022 /PRNewswire/ -- Tyber Medical LLC, the global, leading private-label medical device provider for major orthopedic trauma, extremity, and spine companies, has been awarded a U.S. Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System .
- "We are pleased to receive another FDA clearance that extends our reach into the orthopedic device market with our ever-growing suite of cleared bone-fixation devices," said Tyber Medical CEO and President Jeff Tyber.
- According to Tyber Medical's Senior Project Engineer Abe Perryman, physicians have responded favorably to the company's new staple system.
- Tyber Medical's NiTy+ One-Shot Staple Fixation System consists of sterile, single-use orthopedic implants and fully disposable instruments, removing the need for facility reprocessing.
