Osteomedics, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Osteomedics, Inc. makes
Osteomedics, Inc. manufactures orthopedic fixation devices, including titanium plating systems for calcaneus and osteotomy, external fixation systems for bone transport and extremity stabilization, mandibular and jaw distraction devices, and small fragment fixation systems. Their portfolio also includes resorbable fixation solutions and reconstruction systems for the distal radius.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. The company’s products are listed in the FDA’s 510(k) registry, reflecting compliance with US medical device regulations. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Normed Mini External Fixator System Ref K022230
Regimes: 510(k) Registry: 510(k)Normed Mandibular Fixation System Ref K010118
Regimes: 510(k) Registry: 510(k)Normed Bone Transport Distraction Device Ref K021341
Regimes: 510(k) Registry: 510(k)Normed Titanium Osteotomy Plating System Ref K022325
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Normed Distal Radius Reconstruction System Ref K022231
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Osteomedics, Inc. have in the registry?
The registry currently lists 10 devices for Osteomedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osteomedics, Inc.'s devices?
Among its 10 most recently registered devices, Osteomedics, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Osteomedics, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Osteomedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Osteomedics, Inc. in the registry?
The most recently registered devices listed for Osteomedics, Inc. include NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM, NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM, NORMED MINI EXTERNAL FIXATOR SYSTEM and NORMED MANDIBULAR FIXATION SYSTEM.