Cleared Traditional

ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL

K102262 · Arthrocare Corp. · Orthopedic
Oct 2010
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K102262 is an FDA 510(k) clearance for the ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; 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 October 21, 2010, 72 days after receiving the submission on August 10, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K102262 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2010
Decision Date October 21, 2010
Days to Decision 72 days
Submission Type Traditional
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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