Osteoimplant Technology, Inc.
United StatesFDA applicant, unverified
- Devices
- 21
What Osteoimplant Technology, Inc. makes
Osteoimplant Technology, Inc. manufactures modular and non-modular total hip systems, including cemented and cementless femoral components, alumina ceramic femoral heads, and interpositional spacers for hip arthroplasty. Their portfolio also includes modular shoulder systems designed for shoulder arthroplasty, with variations for different fixation methods and head materials.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Search and filter all 21 devicesFrequently asked questions
How many devices does Osteoimplant Technology, Inc. have in the registry?
The registry currently lists 21 devices for Osteoimplant Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osteoimplant Technology, Inc.'s devices?
Among its 21 most recently registered devices, Osteoimplant Technology, Inc. has devices listed in FDA 510(k) (21 devices).
What risk classes do Osteoimplant Technology, Inc.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for Osteoimplant Technology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Osteoimplant Technology, Inc. in the registry?
The most recently registered devices listed for Osteoimplant Technology, Inc. include OMEGA HA COATED TOTAL HIP SYSTEM, OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS, OTI MODULAR SHOULDER SYSTEM and OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION).