Cement Restrictor TPA-8
by Tecres
Cement Restrictor TPA-8 is a Class II device made by Tecres, cleared under FDA 510(k) K021765 on 16 Aug 2002 and listed in FDA GUDID since 12 Oct 2015 (UDI-DI 08031497001562), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08031497001562 | Date12 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK021765 | Date16 Aug 2002 | StatusActive |
Official records
- AccessGUDID record 08031497001562
- FDA 510(k) database K021765
Across registries
- FDA 510(k) K021765 decided 16 Aug 2002 Active
- FDA GUDID UDI-DI 08031497001562 listed 12 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K021765
- Listed FDA GUDID 08031497001562
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cement Restrictor
- Generic name
- Polymer orthopaedic cement restrictor, non-bioabsorbable
- Model / reference
- TPA-8
- Primary DI / UDI-DI
- 08031497001562
- 510(k) Number
- FDA product code
- JDK
- GMDN term
- Polymer orthopaedic cement restrictor, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 8 Millimeter
Similar devices
Other devices filed under FDA product code JDK (Prosthesis, Hip, Cement Restrictor).
- SPINAL USA CEMENT RESTRICTOR SYSTEM by Spinal USA, LLC
- CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR by Centerpulse Spine-Tech, Inc.
- INTERPORE CROSS CEMENT RESTRICTOR by Interpore Cross Intl.
- OSTEONICS(R) MID-SHAFT CEMENT SPACER by Osteonics Corp.
- MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR by MEDTRONIC SOFAMOR DANEK, INC.
- NOVASPINE CEMENT RESTRICTOR NSCR by Novaspine, LLC
- QUANTUM CEMENT RESTRICTOR by Quantum Orthopedics, Inc.
- OMNIFIT DISTAL STEM CEMENT SPACERS by Osteonics Corp.
- LIMA CEMENT RESTRICTOR by Turnkey Intergration USA, Inc.
- MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR by Life Spine, Inc.