Osteonics Corp.
United StatesFDA applicant, unverified
- Devices
- 178
What Osteonics Corp. makes
Osteonics Corp. manufactures orthopedic implants for joint replacement, including modular hip stems (cemented and uncemented), acetabular components, elbow prostheses, and knee tibial components. Their portfolio includes specialized femoral heads, shoulder humeral prostheses, and acetabular cups designed for primary and revision surgeries. The company also produces fixation devices such as interlaminar clamps for spinal applications.
The company’s devices are classified under FDA regulations as Class I, Class II, and Class III, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, reflecting their regulatory clearance status. The manufacturer operates from the United States.
Catalogue
Search and filter all 178 devicesShowing 1-50 of 178
Frequently asked questions
How many devices does Osteonics Corp. have in the registry?
The registry currently lists 178 devices for Osteonics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osteonics Corp.'s devices?
Among its 50 most recently registered devices, Osteonics Corp. has devices listed in FDA 510(k) (50 devices).
What risk classes do Osteonics Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Osteonics Corp.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Osteonics Corp. in the registry?
The most recently registered devices listed for Osteonics Corp. include OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM, OMNIFIT II HIP PROSTHESES: CEMENT FIXATION, OSTEONICS TOTAL ELBOW SYSTEM and MC2P ACETABULAR COMPONENT.