Cleared Special

5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL

K110164 · Arthrocare Corp. · Orthopedic
Feb 2011
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K110164 is an FDA 510(k) clearance for the 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL, 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 February 7, 2011, 19 days after receiving the submission on January 19, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K110164 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2011
Decision Date February 07, 2011
Days to Decision 19 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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