Bold 131016SND
by Newdeal Sas
Bold 131016SND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K011262 on 15 Jun 2001 and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780055051), 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 | Number10381780055051 | Date9 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011262 | Date15 Jun 2001 | StatusActive |
Official records
- AccessGUDID record 10381780055051
- FDA 510(k) database K011262
Across registries
- FDA 510(k) K011262 decided 15 Jun 2001 Active
- FDA GUDID UDI-DI 10381780055051 listed 9 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K011262
- Listed FDA GUDID 10381780055051
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bold
- Generic name
- Orthopaedic bone screw, non-bioabsorbable, sterile
- Model / Ref / Catalog
- 131016SND
- Primary DI / UDI-DI
- 10381780055051
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Orthopaedic bone screw, non-bioabsorbable, sterile
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
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