Opus Speedlock Knotless Fixation Device

• • Terminated Z-1952-2011 FDA Unclassified (pre-2012) ·initiated 30 Sep 2010

  During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.

510(k) Number

K090615 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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