Gpc ILB39.28T
Gpc ILB39.28T is a Class II device made by Gpc Medical, Ltd., cleared under FDA 510(k) K203811 on 10 Feb 2022 and listed in FDA GUDID since 19 Sep 2025 (UDI-DI 08905892039416), 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 | Number08905892039416 | Date19 Sep 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203811 | Date10 Feb 2022 | StatusActive |
Official records
- AccessGUDID record 08905892039416
- FDA 510(k) database K203811
Across registries
- FDA 510(k) K203811 decided 10 Feb 2022 Active
- FDA GUDID UDI-DI 08905892039416 listed 19 Sep 2025 Listed
Timeline
- Cleared FDA 510(k) K203811
- Listed FDA GUDID 08905892039416
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gpc
- Generic name
- Femoral neck fixation sliding bone screw
- Model / reference
- ILB39.28T
- Primary DI / UDI-DI
- 08905892039416
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Femoral neck fixation sliding bone screw
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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