03.010.438S
by Synthes GmbH
03.010.438S (03010438S) is a Class II device made by Synthes GmbH, cleared under FDA 510(k) K111667 on 5 Dec 2011 and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 10886982068798), active as of 12 Nov 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 | GUDID listing | Number10886982068798 | Date14 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111667 | Date5 Dec 2011 | StatusActive |
Official records
- AccessGUDID record 10886982068798
- FDA 510(k) database K111667
Across registries
- FDA 510(k) K111667 decided 5 Dec 2011 Active
- FDA GUDID UDI-DI 10886982068798 listed 14 Sep 2015 Listed
Recalls
-
- Terminated Z-0404-2014
Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar.
Timeline
- Cleared FDA 510(k) K111667
- Recall initiated FDA recalls Z-0404-2014
- Listed FDA GUDID 10886982068798
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Orthopaedic implantation sleeve, single-use
- Model / Ref / Catalog
- 03.010.438S, 03010438S
- Primary DI / UDI-DI
- 10886982068798
- 510(k) Number
- FDA product code
- JDS
- GMDN term
- Orthopaedic implantation sleeve, single-use
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Orthopaedic implantation sleeve, single-use.