Small Bone Locking Plating System
510(k) K081546
Small Bone Locking Plating System is a Class II device made by Depuy Orthopaedics, Inc., cleared under FDA 510(k) K081546 on 26 Aug 2008, 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 | NumberK081546 | Date26 Aug 2008 | StatusActive |
Official records
- FDA 510(k) database K081546
Recalls
-
- Terminated Z-2965-2018
A size 22mm threaded peg was found in the package of a 10mm unit.
Timeline
- Cleared FDA 510(k) K081546
- Recall initiated FDA recalls Z-2965-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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