Sutter Corp.
United StatesFDA applicant, unverified
- Devices
- 7
What Sutter Corp. makes
Sutter Corp. manufactures continuous passive motion (CPM) devices for joint rehabilitation, including hand, leg, ankle, and hospital-use models, as well as joint prostheses and motion splints for foot and toe conditions.
Their products are regulated under FDA Class I and Class II classifications, with some devices authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Sutter Model 6000 Hand Cpm Device Ref K945221
Regimes: 510(k) Registry: 510(k)Sutter Model 10000 Leg Cpm Device Ref K914860
Regimes: 510(k) Registry: 510(k)Sutter Hospital Cpm Ref K890607
Regimes: 510(k) Registry: 510(k)Sutter Hammertoe Joint Prosthesis Ref K943354
Regimes: 510(k) Registry: 510(k)Sutter Proximal Interphalangeal Joint Ref K931588
Regimes: 510(k) Registry: 510(k)Model 9000 At Ankle Cpm Device Ref K902707
Regimes: 510(k) Registry: 510(k)First Metatarsophalangeal Joint Motion Splint Ref K924654
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sutter Corp. have in the registry?
The registry currently lists 7 devices for Sutter Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sutter Corp.'s devices?
Among its 7 most recently registered devices, Sutter Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Sutter Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Sutter Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sutter Corp. in the registry?
The most recently registered devices listed for Sutter Corp. include SUTTER MODEL 6000 HAND CPM DEVICE, SUTTER MODEL 10000 LEG CPM DEVICE, SUTTER HOSPITAL CPM and SUTTER HAMMERTOE JOINT PROSTHESIS.