Gmk Extension

510(k) Number

K142069 ↗

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).

• PHYSICA KR 6532.54.120 by Limacorporate
• PHYSICA CR Tibial Liner 6533.50.811 by Limacorporate
• PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI by Johnson & Johnson Orthopaedics, Inc.
• ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM by Conformis, Inc.
• Unity Total Knee System 1236203 by CORIN LTD
• APEX PS Knee KP-0045L by OMNIlife science, Inc.
• APEX PS Knee KP-20516 by OMNIlife science, Inc.
• Persona® 42-5870-010-02 by Zimmer, Inc.
• Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS by Conformis, Inc.
• NexGen® Legacy® 5995-13-92 00-5995-013-92 by Zimmer, Inc.

• 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 →