Orthomatrix, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Orthomatrix, Inc. makes
Orthomatrix, Inc. manufactures orthopedic and dental implants, including hydroxyapatite-based materials for bone grafting and tooth root substitution, such as the HA-1000, HA-500, and HA-2000. Their portfolio also includes intramedullary nails for humeral and tibial fixation (e.g., the Magellan systems), a cannulated screw system for bone stabilization, and mesh-based bone graft materials like Ridgematrix and Periomatrix. Additional products include a cerclage system for internal bone fixation.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) clearance registry. Orthomatrix, Inc. is headquartered in the United States.
Catalogue
Ha-1000 & Ha-500 Hydroxylapatite-Modification Ref K851367
Regimes: 510(k) Registry: 510(k)Ha-2000 Hydroxylapatite Ref K852765
Regimes: 510(k) Registry: 510(k)Cannulated Plus Screw System Ref K010738
Regimes: 510(k) Registry: 510(k)Ridgematrix 20/40 Mesh, Periomatrix Ref K842163
Regimes: 510(k) Registry: 510(k)Magellan Humeral Intramedullary Nail Ref K992856
Regimes: 510(k) Registry: 510(k)Orthomatrix, Inc. Cerclage System Ref K001254
Regimes: 510(k) Registry: 510(k)Magellan Tibial Intramedullary Nail Ref K992850
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orthomatrix, Inc. have in the registry?
The registry currently lists 8 devices for Orthomatrix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthomatrix, Inc.'s devices?
Among its 8 most recently registered devices, Orthomatrix, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Orthomatrix, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Orthomatrix, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orthomatrix, Inc. in the registry?
The most recently registered devices listed for Orthomatrix, Inc. include HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION, HA-2000 HYDROXYLAPATITE, CANNULATED PLUS SCREW SYSTEM and RIDGEMATRIX 20/40 MESH, PERIOMATRIX.