EVOS Lumbar Interbody System 4282-012
EVOS Lumbar Interbody System 4282-012 is a Class II device made by Cutting Edge Spine, cleared under FDA 510(k) K150321 on 13 Jul 2015 and listed in FDA GUDID since 27 Nov 2015 (UDI-DI 00841193111308), 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 | Number00841193111308 | Date27 Nov 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150321 | Date13 Jul 2015 | StatusActive |
Official records
- AccessGUDID record 00841193111308
- FDA 510(k) database K150321
Across registries
- FDA 510(k) K150321 decided 13 Jul 2015 Active
- FDA GUDID UDI-DI 00841193111308 listed 27 Nov 2015 Listed
Timeline
- Cleared FDA 510(k) K150321
- Listed FDA GUDID 00841193111308
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EVOS Lumbar Interbody System
- Generic name
- Polymeric spinal fusion cage, sterile
- Model / Ref / Catalog
- 4282-012
- Description
- HA PEEK EVOS Rotate, , 12mmx10mmx 30mm , BICONVEX 0 degree
- Primary DI / UDI-DI
- 00841193111308
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Polymeric spinal fusion cage, sterile
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 30 Millimeter