Stryker Patient Specific Polymer Implant

• • Terminated Z-0975-2014 FDA Class II ·initiated 6 Dec 2013

  Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.

510(k) Number

K103010 ↗

FDA Product Code

KKY

Device Class

Class II

Regulation

21 CFR Part 878.3500

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Howmedica Osteonics Corp., Dba Stryker Orthopaedics →