Opus Speedscrew System

• • Terminated Z-0614-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011

  Product is being removed from the field due to an over-label issue.

510(k) Number

K101448 ↗

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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  Class IIb

  CE/MDR

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  Class II

  FDA 510(k) K000511 Active Cleared 13 Mar 2000

See all devices from ArthroCare Corporation →