Orthopedic Source, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Orthopedic Source, Inc. makes
Orthopedic Source, Inc. manufactures hip replacement systems, including the Avalon Cup System and its modification, as well as press-fit hip implants designed for orthopedic surgery.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Modification To Avalon Cup System Ref K022711
Regimes: 510(k) Registry: 510(k)Orthopedic Source Press-Fit Hip Ref K061124
Regimes: 510(k) Registry: 510(k)Avalon Cup System Ref K011887
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orthopedic Source, Inc. have in the registry?
The registry currently lists 3 devices for Orthopedic Source, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthopedic Source, Inc.'s devices?
Among its 3 most recently registered devices, Orthopedic Source, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Orthopedic Source, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Orthopedic Source, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orthopedic Source, Inc. in the registry?
The most recently registered devices listed for Orthopedic Source, Inc. include MODIFICATION TO AVALON CUP SYSTEM, ORTHOPEDIC SOURCE PRESS-FIT HIP and AVALON CUP SYSTEM.