Monterey AL Interbody System
510(k) K201585
Monterey AL Interbody System is a Class II device made by Stryker Corporation, cleared under FDA 510(k) K201585 on 10 Aug 2020, active as of 22 Oct 2026. 4 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
4 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201585 | Date10 Aug 2020 | StatusActive |
Official records
- FDA 510(k) database K201585
Recalls
-
- Ongoing Z-1491-2025
- Ongoing Z-1490-2025
- Ongoing Z-1488-2025
- Ongoing Z-1489-2025
Potential for the gold unlock button to separate from the inserter.
Timeline
- Cleared FDA 510(k) K201585
- Recall initiated FDA recalls Z-1491-2025
- Recall initiated FDA recalls Z-1490-2025
- Recall initiated FDA recalls Z-1488-2025
- Recall initiated FDA recalls Z-1489-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OVD
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent