The JASPER Spinal Fixation System L188-5145
by GBS Commonwealth Co., Ltd. 2 variants
The JASPER Spinal Fixation System L188-5145 is a Class II device made by GBS Commonwealth Co., Ltd., cleared under FDA 510(k) K173645 on 23 Jul 2018 and listed in FDA GUDID since 30 Mar 2019 (UDI-DI 08800033182290), 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 | Number08800033182290 | Date30 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173645 | Date23 Jul 2018 | StatusActive |
Official records
- AccessGUDID record 08800033182290
- FDA 510(k) database K173645
Across registries
- FDA 510(k) K173645 decided 23 Jul 2018 Active
- FDA GUDID UDI-DI 08800033182290 listed 30 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K173645
- Listed FDA GUDID 08800033182290
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- Withdrawn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 connector
- Model / reference
- L188-5145
- Primary DI / UDI-DI
- 08800033182290
- 510(k) Number
- FDA product code
- NKB
- GMDN term
- Bone-screw internal spinal fixation system connector
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Bone-screw internal spinal fixation system connector.