Simpex Kirschner Wire TK-054-4S
Simpex Kirschner Wire TK-054-4S is a Class II device made by Simpex Medical, Inc., cleared under FDA 510(k) K911505 on 12 Apr 1991 and listed in FDA GUDID since 23 Sep 2015 (UDI-DI B068TK0544S1), 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 | NumberB068TK0544S1 | Date23 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK911505 | Date12 Apr 1991 | StatusActive |
Official records
- FDA 510(k) database K911505
Across registries
- FDA 510(k) K911505 decided 12 Apr 1991 Active
- FDA GUDID UDI-DI B068TK0544S1 listed 23 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K911505
- Listed FDA GUDID B068TK0544S1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Simpex Kirschner Wire
- Generic name
- Orthopaedic bone wire
- Model / Ref / Catalog
- TK-054-4S
- Primary DI / UDI-DI
- B068TK0544S1
- 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
- Size
- Length — 102 MillimeterOuter Diameter — 1.4 Millimeter