Lumbar IBFD 23L x 10W x 6H Straight, HA
by Keos
Lumbar IBFD 23L x 10W x 6H Straight, HA (KPS2-231006) is a Class II device made by Keos, cleared under FDA 510(k) K193174 on 16 Dec 2019 (2 earlier submissions) and listed in FDA GUDID since 22 Feb 2018 (UDI-DI B084KPS22310060), 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 | FDA 510(k)SESE | NumberK193174 | Date16 Dec 2019 | StatusActive |
| United States | GUDID listing | NumberB084KPS22310060 | Date22 Feb 2018 | StatusListed |
Official records
- FDA 510(k) database K193174
- FDA 510(k) database K163386
- FDA 510(k) database K160631
Across registries
- FDA 510(k) K193174 decided 16 Dec 2019 Active
- FDA GUDID UDI-DI B084KPS22310060 listed 22 Feb 2018 Listed
Timeline
- Cleared FDA 510(k) K160631
- Cleared FDA 510(k) K163386
- Listed FDA GUDID B084KPS22310060
- Cleared FDA 510(k) K193174
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lumbar IBFD
- Generic name
- Polymeric spinal interbody fusion cage
- Model / Ref / Catalog
- 23L x 10W x 6H Straight, HA, KPS2-231006
- Primary DI / UDI-DI
- B084KPS22310060
- FDA product code
- MAX
- GMDN term
- Polymeric spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization