Bold 131018SND
by Newdeal Sas
Bold 131018SND 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 10381780055075), 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 | Number10381780055075 | Date9 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011262 | Date15 Jun 2001 | StatusActive |
Official records
- AccessGUDID record 10381780055075
- FDA 510(k) database K011262
Across registries
- FDA 510(k) K011262 decided 15 Jun 2001 Active
- FDA GUDID UDI-DI 10381780055075 listed 9 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K011262
- Listed FDA GUDID 10381780055075
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- Withdrawn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
- 131018SND
- Primary DI / UDI-DI
- 10381780055075
- 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
Similar devices in this category
Other devices filed under Orthopaedic bone screw, non-bioabsorbable, sterile.
- OsteoMed 317-2420-SP-05 by Osteomed Corp.
- PEG FULLY THREADED, LOCKING 1312-12-610 131212610 by Biomet Orthopedics, Inc.
- Centronail Titanium Tibial Nailing System 1 99-T746025 by Orthofix, Inc.
- ACUMED AT2-C12-S by ACUMED LLC
- ACUMED CO-N2320-S by ACUMED LLC
- Mpact Extension 01.43.0035 by Medacta International
- G-Beam Fusion Beaming System 1 99-877075 by Orthofix, Inc.
- A.L.P.S.® 110017614 by Biomet Orthopedics, Inc.
- 6624-65-60 00-6624-065-60 by Zimmer, Inc.
- Mpact Extension 01.43.0065 by Medacta International