Hallu-Fix 117150SND
by Newdeal Sas
Hallu-Fix 117150SND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K093781 on 22 Jan 2010 and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780043362), 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 | Number10381780043362 | Date9 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093781 | Date22 Jan 2010 | StatusActive |
Official records
- AccessGUDID record 10381780043362
- FDA 510(k) database K093781
Across registries
- FDA 510(k) K093781 decided 22 Jan 2010 Active
- FDA GUDID UDI-DI 10381780043362 listed 9 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K093781
- Listed FDA GUDID 10381780043362
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- Withdrawn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
- Model / Ref / Catalog
- 117150SND
- Primary DI / UDI-DI
- 10381780043362
- 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
Similar devices in this category
Other devices filed under Orthopaedic fixation plate, non-bioabsorbable.
- LOQTEQ® PR 3550-08-2 by aap Implantate AG
- Arthrex® AR-8963PLL-06 by Arthrex, Inc.
- ACUMED 7007-0106L by ACUMED LLC
- Arthrex® AR-8916VSR-03 by Arthrex, Inc.
- Piccolo Composite Plate System Diaphyseal Plate - Narrow PLCNN4509 by CARBOFIX ORTHOPEDICS LTD
- DVR® CROSSLOCK 1318-12-061 131812061 by Biomet Orthopedics, Inc.
- OsteoMed 333-1608 by Osteomed Corp.
- LOQTEQ® PA 3531-04-2 by aap Implantate AG
- OsteoMed 336-2225 by Osteomed Corp.
- LCP T-adaption plate 2.4 F14AB-PA00848 by WUHAN MINDRAY SCIENTIFIC CO., LTD.