M.U.S.T Pedicle Screw System
by Medacta International 2 variants
510(k) K121115
M.U.S.T Pedicle Screw System is a Class II device made by Medacta International, cleared under FDA 510(k) K121115 on 18 Jul 2012, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121115 | Date18 Jul 2012 | StatusActive |
Official records
- FDA 510(k) database K121115
Recalls
-
- Terminated Z-1023-2017
Damaged packaging, lack of sterility assurance
Timeline
- Cleared FDA 510(k) K121115
- Recall initiated FDA recalls Z-1023-2017
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent