CastleLoc Pectus Bar System
510(k) K243357
CastleLoc Pectus Bar System is a Class II device made by L&K Biomed Co., Ltd., cleared under FDA 510(k) K243357 on 27 Feb 2025 and listed in FDA GUDID since 30 May 2025 (UDI-DI 08809986482167), active as of 22 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 GUDID | Number08809986482167 | Date30 May 2025 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | NumberK243357 | Date27 Feb 2025 | StatusActive |
Official records
- AccessGUDID record 08809986482167
- FDA 510(k) database K243357
Across registries
- FDA 510(k) K243357 decided 27 Feb 2025 Active
- FDA GUDID UDI-DI 08809986482167 listed 30 May 2025 Listed
Timeline
- Cleared FDA 510(k) K243357
- Listed FDA GUDID 08809986482167
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Rib/rib cage internal fixation/bracing system bracing bar
- Model / reference
- PB12-0015
- Primary DI / UDI-DI
- 08809986482167
- 510(k) Number
- FDA product code
- HRS
- GMDN term
- Rib/rib cage internal fixation/bracing system bracing bar
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization