EXPert Nail 04.003.002
by Synthes GmbH
EXPert Nail 04.003.002 (04003002) is a Class II device made by Synthes GmbH, cleared under FDA 510(k) K172157 on 14 Nov 2017 (2 earlier submissions) and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 10886982081339), active as of 12 Nov 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172157 | Date14 Nov 2017 | StatusActive |
| United States | GUDID listing | Number10886982081339 | Date14 Sep 2015 | StatusListed |
Official records
- AccessGUDID record 10886982081339
- FDA 510(k) database K172157
- FDA 510(k) database K040336
- FDA 510(k) database K033618
Across registries
- FDA 510(k) K172157 decided 14 Nov 2017 Active
- FDA GUDID UDI-DI 10886982081339 listed 14 Sep 2015 Listed
Recalls
-
- Terminated Z-1915-2015
certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components).
-
- 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
- Cleared FDA 510(k) K040336
- Recall initiated FDA recalls Z-2058-2013
- Recall initiated FDA recalls Z-1915-2015
- Listed FDA GUDID 10886982081339
- Cleared FDA 510(k) K172157
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EXPert Nail
- Generic name
- Bone nail implantable cap
- Model / Ref / Catalog
- 04.003.002, 04003002
- Primary DI / UDI-DI
- 10886982081339
- FDA product code
- HSB, HWC
- GMDN term
- Bone nail implantable cap
- Device class
- Class II
- Regulation number
- 888.3020, 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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