Cleared Special

5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP

K110781 · Arthrocare Corp. · Orthopedic
May 2011
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K110781 is an FDA 510(k) clearance for the 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on May 27, 2011, 67 days after receiving the submission on March 21, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K110781 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2011
Decision Date May 27, 2011
Days to Decision 67 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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