Threaded Cement Restrictor (Cr) Titanium
by Medtronic Sofamor Danek USA, Inc.
510(k) K011443
Threaded Cement Restrictor (Cr) Titanium is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K011443 on 3 Aug 2001, 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 | NumberK011443 | Date3 Aug 2001 | StatusActive |
Official records
- FDA 510(k) database K011443
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- Withdrawn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
Devices cleared under K011443
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| X1203056 | X1203056 | 00885074000770 | — | On the market |
Similar devices
Other devices filed under FDA product code JDK (Prosthesis, Hip, Cement Restrictor).
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- NOVASPINE CEMENT RESTRICTOR NSCR by Novaspine, LLC
- QUANTUM CEMENT RESTRICTOR by Quantum Orthopedics, Inc.
- Cement Restrictor TPA-24 by Tecres