Cleared Traditional

Adjustable Fixation Device

K153186 · Arthrocare Corp. · Orthopedic
Jan 2016
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K153186 is an FDA 510(k) clearance for the Adjustable Fixation Device, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Arthrocare Corp. (Irvine, US). The FDA issued a Cleared decision on January 28, 2016, 86 days after receiving the submission on November 3, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K153186 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2015
Decision Date January 28, 2016
Days to Decision 86 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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