Hallu-Fix 117160ND
by Newdeal Sas
Hallu-Fix 117160ND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K093781 on 22 Jan 2010 (1 earlier submission) and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780043393), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10381780043393 | Date9 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093781 | Date22 Jan 2010 | StatusActive |
Official records
- AccessGUDID record 10381780043393
- FDA 510(k) database K093781
- FDA 510(k) database K021626
Across registries
- FDA 510(k) K093781 decided 22 Jan 2010 Active
- FDA GUDID UDI-DI 10381780043393 listed 9 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K021626
- Cleared FDA 510(k) K093781
- Listed FDA GUDID 10381780043393
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hallu-Fix
- Generic name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile
- Model / Ref / Catalog
- 117160ND
- Primary DI / UDI-DI
- 10381780043393
- FDA product code
- HRS
- GMDN term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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