Rotation Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Rotation Medical, Inc. makes
Rotation Medical, Inc. manufactures collagen-based tendon sheets and surgical staples for soft tissue and bone applications, including the CTS-DDI, CTS-D, RMST Staple, and RMB Staple.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Collagen Tendon Sheet-Ddi (Cts-Ddi) Ref K140300
Regimes: 510(k) Registry: 510(k)Collagen Tendon Sheet Ref K112423
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Collagen Tendon Sheet-D Ref K122048
Regimes: 510(k) Registry: 510(k)Rotation Medical Bone Staple (Rmb Staple) Ref K131635
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rotation Medical, Inc. have in the registry?
The registry currently lists 5 devices for Rotation Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rotation Medical, Inc.'s devices?
Among its 5 most recently registered devices, Rotation Medical, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Rotation Medical, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Rotation Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rotation Medical, Inc. in the registry?
The most recently registered devices listed for Rotation Medical, Inc. include COLLAGEN TENDON SHEET-DDI (CTS-DDI), COLLAGEN TENDON SHEET, ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) and COLLAGEN TENDON SHEET-D.