Gmk - Line Extension

510(k) Number

K120790 ↗

FDA product code

JWH

Device class

Class II

Regulation

21 CFR Part 888.3560

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

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.

Other devices filed under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

• APEX Knee System KC-55204 by OMNIlife science, Inc.
• Unity Total Knee System 112.017.06 by CORIN LTD
• GMK Hinge and Revision TiNbN coated 02.07.7404FDW by Medacta International SA
• All poly tibial component, UC 2203-1465 by UNITED ORTHOPEDIC CORP.
• Persona® 42-5868-070-15 by Zimmer, Inc.
• 3DMetal Tibial Cones 02.07.CL25 by Medacta International SA
• APEX Knee System EP-22511 by OMNIlife science, Inc.
• Unity Total Knee System 123.368.09 by CORIN LTD
• Persona® 42-5830-075-14 by Zimmer, Inc.
• PHYSICA TT 6521.14.020 by Limacorporate

• Versafitcup Cc Trio

  Class II

  FDA 510(k) K103352 Active Cleared 11 Feb 2011

• Mectalif

  Class II

  FDA 510(k) K131671 Active Cleared 5 Jul 2013

• Meta-C Cervical Plate

  Class II

  FDA 510(k) K140361 Active Cleared 12 Jun 2014

• Gmk Sphere

  Class II

  FDA 510(k) K121416 Active Cleared 20 Jul 2012

See all devices from Medacta International →