ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
FDA 510(k) clearance K131637 · decided 2013-07-12
Clearance details
- K-number
- K131637
- Device name
- ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
- Applicant
- Rotation Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-04
- Decision date
- 2013-07-12
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic recall (Z-3096-2024) | Smith & Nephew Inc. | 2024-09-10 |
| ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prostheti recall (Z-3097-2024) | Smith & Nephew Inc. | 2024-09-10 |