Nuvasive Cement Restrictor
510(k) K032180
Nuvasive Cement Restrictor is a Class II device made by Nuvasive, Inc., cleared under FDA 510(k) K032180 on 7 Oct 2003, 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)SESU | NumberK032180 | Date7 Oct 2003 | StatusActive |
Official records
- FDA 510(k) database K032180
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JDK
- Device class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESU
Similar devices
Other devices filed under FDA product code JDK (Prosthesis, Hip, Cement Restrictor).
- TITANIUM CEMENT RESTRICTOR (TCR) by MEDTRONIC SOFAMOR DANEK, INC.
- DOSIMETRY RELEASE OF RADIATION STERILIZ by Biomet, Inc.
- PROXIMAL CEMENT SPACER by Osteonics Reconstructive Products Div.
- Cement Restrictor TPA-18 by Tecres
- OSTEONICS CEMENT RESTRICTOR by Osteonics Corp.
- CADENCE PEEK CEMEENT RESTRICTOR by Spinal Concepts, Inc.
- LIFE SPINE CEMENT RESTRICTOR by Life Spine, Inc.
- PT DISTAL TIP CEMENT SPACER by Osteonics Corp.
- FIDJI SMALL CEMENT RESTRICTOR by Spine Next SA
- SKELITE RESORBABLE CEMENT RESTRICTOR by Millenium Biologix, Inc.