Fischer Wire/Pin Clamp

• • Terminated Z-0508-2012 FDA Unclassified (pre-2012) ·initiated 8 Nov 2011

  DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the inability to properly thread the nut onto the bolt.

510(k) Number

K860018 ↗

FDA Product Code

HXK

Device Class

Class I

Regulation

21 CFR Part 888.4540

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Buckman Co., Inc. →