Osteo Technology, Inc.
United StatesFDA applicant, unverified
- Devices
- 21
What Osteo Technology, Inc. makes
Osteo Technology, Inc. manufactures orthopedic implants for joint replacement and fracture fixation, including hip and shoulder prosthesis systems, femoral stems, intramedullary rods, and bone fixation cups. Their portfolio includes specific designs such as the Mueller femoral stem, Neer shoulder prosthesis, and Charnley hip prosthesis, as well as modular components like bone plugs and fixation screws.
The company’s devices are regulated under FDA Class I, II, and III classifications, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Search and filter all 21 devicesFrequently asked questions
How many devices does Osteo Technology, Inc. have in the registry?
The registry currently lists 21 devices for Osteo Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osteo Technology, Inc.'s devices?
Among its 21 most recently registered devices, Osteo Technology, Inc. has devices listed in FDA 510(k) (21 devices).
What risk classes do Osteo Technology, Inc.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for Osteo Technology, Inc.'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 Osteo Technology, Inc. in the registry?
The most recently registered devices listed for Osteo Technology, Inc. include REPLICA TOTAL HIP SYSTEM, BIOMETRIC SCREW FIXATION CUP, REPLICA(TM) TOTAL HIP SYSTEM and MUELLER TYPE FEMORAL STEM.