Cleared Traditional

3.9MM REELX STT SUTURE ANCHOR SYSTEM

K120824 · Stryker Corp. · Orthopedic
Jul 2012
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K120824 is an FDA 510(k) clearance for the 3.9MM REELX STT SUTURE ANCHOR SYSTEM, 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 July 18, 2012, 121 days after receiving the submission on March 19, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K120824 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2012
Decision Date July 18, 2012
Days to Decision 121 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