Cleared Special

K100457 - OPUS SPEEDSCREW SYSTEM
(FDA 510(k) Clearance)

K100457 · Arthrocare Corp. · Orthopedic

Mar 2010

Decision

30d

Days

Class 2

Risk

K100457 is an FDA 510(k) clearance for the OPUS SPEEDSCREW SYSTEM, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Arthrocare Corp. (Irvine, US). The FDA issued a Cleared decision on March 19, 2010, 30 days after receiving the submission on February 17, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K100457 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2010
Decision Date	March 19, 2010
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF