Cleared Traditional

ICONIX ALL SUTURE ANCHORS

K133671 · Stryker Corp. · Orthopedic
Feb 2014
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K133671 is an FDA 510(k) clearance for the ICONIX ALL SUTURE ANCHORS, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Stryker Corp. (Denver, US). The FDA issued a Cleared decision on February 28, 2014, 91 days after receiving the submission on November 29, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K133671 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2013
Decision Date February 28, 2014
Days to Decision 91 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