The JASPER Spinal Fixation System L237-6050
The JASPER Spinal Fixation System L237-6050 is a Class II device made by GBS Commonwealth Co., Ltd., cleared under FDA 510(k) K190762 on 19 Jun 2019 and listed in FDA GUDID since 30 Sep 2019 (UDI-DI 08800033888918), 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 | Number08800033888918 | Date30 Sep 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190762 | Date19 Jun 2019 | StatusActive |
Official records
- AccessGUDID record 08800033888918
- FDA 510(k) database K190762
Across registries
- FDA 510(k) K190762 decided 19 Jun 2019 Active
- FDA GUDID UDI-DI 08800033888918 listed 30 Sep 2019 Listed
Timeline
- Cleared FDA 510(k) K190762
- Listed FDA GUDID 08800033888918
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- The JASPER Spinal Fixation System
- Generic name
- Bone-screw internal spinal fixation system, non-sterile
- Model / reference
- L237-6050
- Primary DI / UDI-DI
- 08800033888918
- 510(k) Number
- FDA product code
- NKB
- GMDN term
- Bone-screw internal spinal fixation system, non-sterile
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization