MectaPlug PE II 01.33.204
MectaPlug PE II 01.33.204 is a Class II device made by Medacta International SA, cleared under FDA 510(k) K210062 on 8 Apr 2021 and listed in FDA GUDID since 16 Apr 2021 (UDI-DI 07630345710994), active as of 12 Nov 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 | Number07630345710994 | Date16 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210062 | Date8 Apr 2021 | StatusActive |
Official records
- AccessGUDID record 07630345710994
- FDA 510(k) database K210062
Across registries
- FDA 510(k) K210062 decided 8 Apr 2021 Active
- FDA GUDID UDI-DI 07630345710994 listed 16 Apr 2021 Listed
Timeline
- Cleared FDA 510(k) K210062
- Listed FDA GUDID 07630345710994
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MectaPlug PE II
- Generic name
- Polymer orthopaedic cement restrictor, non-bioabsorbable
- Model / reference
- 01.33.204
- Primary DI / UDI-DI
- 07630345710994
- 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
Similar devices
Other devices filed under FDA product code JDK (Prosthesis, Hip, Cement Restrictor).
- THEKEN SMALL CEMENT RESTRICTOR by Theken Surgical, Llc
- OPTIMESH 500E CEMENT RESTRICTOR by SPINEOLOGY INC.
- THREADED CEMENT RESTRICTOR (CR) TITANIUM by MEDTRONIC SOFAMOR DANEK, INC.
- BARD INTRAMEDULLARY PLUG by C. R. Bard, Inc.
- CEMENT RESTRICTOR, SMALL AND LARGE by Exactech, Inc.
- 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.