Spine System Evolution
510(k) K001080
Spine System Evolution is a Class II device made by Aesculap, Inc., cleared under FDA 510(k) K001080 on 29 Jun 2000, 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 | FDA 510(k)SESE | NumberK001080 | Date29 Jun 2000 | StatusActive |
Official records
- FDA 510(k) database K001080
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal).
- DENALI DEFORMITY SYSTEM by K2M, INC.
- ROMEO Posterior Osteosynthesis System ELL-RD 40 35-N by Spineart
- COFLEX-F by Paradigm Spine, LLC
- CD Horizon™ ModuLeX™ Spinal System G26324500 by MEDTRONIC SOFAMOR DANEK, INC.
- PRIMAL OK INTERSPINOUS FUSION SYSTEM by Osteomed LP
- TENOR SPINAL SYSTEM by Sofamor Danek USA, Inc.
- MODIFICATION TO PASS SPINAL SYSTEM by Encore Orthopedics, Inc.
- KNEE COMPRESSION HOOK SYSTEM by Zimmer, Inc.
- M.U.S.T. MINI Posterior Cervical Screws 03.75.729 by Medacta International SA
- MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.