510(k) K131637 ยท GDW Staple, Implantable
ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
| Applicant | Rotation Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jul 12, 2013 |
| Received | Jun 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131637
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2024 | Smith & Nephew Inc. ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues.
Product Number: 2504-1 Open, Classified |
GDW | None listed |
| Sep 10, 2024 | Smith & Nephew Inc. ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues.
Product Number: 72205201 Open, Classified |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.