Hallu Lock 290155SND
by Newdeal Sas
Hallu Lock 290155SND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K083154 on 10 Jul 2009 and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780044086), 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 | Number10381780044086 | Date9 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083154 | Date10 Jul 2009 | StatusActive |
Official records
- AccessGUDID record 10381780044086
- FDA 510(k) database K083154
Across registries
- FDA 510(k) K083154 decided 10 Jul 2009 Active
- FDA GUDID UDI-DI 10381780044086 listed 9 Oct 2017 Listed
Recalls
-
- Terminated Z-1147-2012
Manufacturing error. The part number which corresponds to the length dimension of : 14 mm. was incorrectly etched on to screws with the actual measurement of: 12 mm.
Timeline
- Cleared FDA 510(k) K083154
- Recall initiated FDA recalls Z-1147-2012
- Listed FDA GUDID 10381780044086
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hallu Lock
- Generic name
- Orthopaedic fixation plate, non-bioabsorbable
- Model / Ref / Catalog
- 290155SND
- Primary DI / UDI-DI
- 10381780044086
- 510(k) Number
- FDA product code
- HRS
- GMDN term
- Orthopaedic fixation plate, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution