EXPert 03.010.508
by Synthes
EXPert 03.010.508 (03010508) is a Class II device made by Synthes, cleared under FDA 510(k) K033618 on 5 Feb 2004 and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 10886982069245), active as of 23 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 | GUDID listing | Number10886982069245 | Date14 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK033618 | Date5 Feb 2004 | StatusActive |
Official records
- AccessGUDID record 10886982069245
- FDA 510(k) database K033618
Across registries
- FDA 510(k) K033618 decided 5 Feb 2004 Active
- FDA GUDID UDI-DI 10886982069245 listed 14 Sep 2015 Listed
Recalls
-
- Terminated Z-2058-2013
Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.
Timeline
- Cleared FDA 510(k) K033618
- Recall initiated FDA recalls Z-2058-2013
- Listed FDA GUDID 10886982069245
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EXPert
- Generic name
- Orthopaedic implantation sleeve, reusable
- Model / Ref / Catalog
- 03.010.508, 03010508
- Primary DI / UDI-DI
- 10886982069245
- 510(k) Number
- FDA product code
- HWC, HSB
- GMDN term
- Orthopaedic implantation sleeve, reusable
- Device class
- Class II
- Regulation number
- 888.3040, 888.3020
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization