Lumbar IBFD 23L x 8W x 7H Straight, HA Enhanced
by Keos
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193174 | Date16 Dec 2019 | StatusActive |
| United States | GUDID listing | NumberB084KPS22308070 | Date30 Nov 2017 | StatusListed |
Official records
- FDA 510(k) database K193174
- FDA 510(k) database K163386
- FDA 510(k) database K160631
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
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- Withdrawn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 8W x 7H Straight, HA Enhanced, KPS2-230807
- Primary DI / UDI-DI
- B084KPS22308070
- 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
Other devices from Keos
Properties
Other properties (9)
- Supplied sterile: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Expiration date: No