Nuvasive Spinal System
510(k) K033546
Nuvasive Spinal System is a Class II device made by Nuvasive, Inc., cleared under FDA 510(k) K033546 on 12 Apr 2004, 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 | NumberK033546 | Date12 Apr 2004 | StatusActive |
Official records
- FDA 510(k) database K033546
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNH
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation).
- Erisma®-LP 18745000 by Clariance, Inc.
- ROMEO posterior osteosynthesis system ELL-RD 13 50-N by Spineart
- MODIFICATION TO CAPSURE PS SYSTEM by Spine Wave, Inc.
- COLORADO II SPINAL SYSTEM by Sofamor Danek USA, Inc.
- CD HORIZON® Spinal System G154211455 by MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System 55840005545 by MEDTRONIC SOFAMOR DANEK, INC.
- Erisma®-LP 18515120 by Clariance, Inc.
- SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM by Medical Device Advisory Development Group
- GLOBAL SPINAL FIXATION SYSTEM by D.K.M. Co., Ltd.
- APEX SPINE SYSTEM W/ COCR RODS by SPINECRAFT LLC