Cleared Traditional

SONGER(TM) CABLE SYSTEM

K913735 · Danek Medical, Inc. · Orthopedic
Nov 1991
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K913735 is an FDA 510(k) clearance for the SONGER(TM) CABLE SYSTEM, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on November 18, 1991, 90 days after receiving the submission on August 20, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K913735 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1991
Decision Date November 18, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code JDQ — Cerclage, Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3010

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