K-Wire 115100ND
by Newdeal Sas
K-Wire 115100ND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K022599 on 30 Oct 2002 and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780045694), 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 | Number10381780045694 | Date9 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK022599 | Date30 Oct 2002 | StatusActive |
Official records
- AccessGUDID record 10381780045694
- FDA 510(k) database K022599
Across registries
- FDA 510(k) K022599 decided 30 Oct 2002 Active
- FDA GUDID UDI-DI 10381780045694 listed 9 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K022599
- Listed FDA GUDID 10381780045694
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- K-Wire
- Generic name
- Orthopaedic bone wire
- Model / Ref / Catalog
- 115100ND
- Primary DI / UDI-DI
- 10381780045694
- 510(k) Number
- FDA product code
- HTY
- GMDN term
- Orthopaedic bone wire
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Orthopaedic bone wire.
- K-WIRE 110018526 by Biomet Orthopedics, Inc.
- ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS OS333523 by ORTHO SOLUTIONS HOLDINGS LIMITED
- Trauma Fixation Systems 14-441054 by Biomet Orthopedics, Inc.
- OsteoMed 320-5011 by Osteomed Corp.
- OsteoMed 320-5016 by Osteomed Corp.
- CHIMAERA Hip Fracture System 1 99-193287 by Orthofix, Inc.