Tornier Cement Restrictor
510(k) K061824
Tornier Cement Restrictor is a Class II device made by Tornier, cleared under FDA 510(k) K061824 on 14 Sep 2006, 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 | NumberK061824 | Date14 Sep 2006 | StatusActive |
Official records
- FDA 510(k) database K061824
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LZN
- Device class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code LZN (Cement Obturator).
- CENTERING PLUG by Allo Pro Corp.
- CEMENTRALIZER DISTAL STEM CENTRALIZER by Depuy, Inc.
- POLYETHYLENE MEDULLARY PLUG - STIIHMER/ by Allo Pro Corp.
- RESORABPLUG by Sofamor Danek Mfg., Inc.
- P.F.C. CEMENT RESTRICTOR by Johnson & Johnson Professionals, Inc.
- SHUTTLE STOP by Isotis NV
- WROUGHT (FORGED) VITALLIUM by Howmedica Corp.
- IMPLEX CEMENT RESTRICTOR SYSTEM by Implex Corp.
- OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS by Osteonics Corp.
- PFC CEMENT RESTRICTOR by Johnson & Johnson Professionals, Inc.