Synthes 6.5mm Midfoot Fusion Bolt

• • Terminated Z-0014-2014 FDA Class II ·initiated 8 Mar 2013

  A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.

510(k) Number

K081071 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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