Cleared Traditional

FX-CABLELOK CABLE/PLATE SYSTEM

K935950 · Buckman Co., Inc. · Orthopedic
Mar 1994
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K935950 is an FDA 510(k) clearance for the FX-CABLELOK CABLE/PLATE SYSTEM, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on March 9, 1994, 86 days after receiving the submission on December 13, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K935950 FDA.gov
FDA Decision Cleared SN
Date Received December 13, 1993
Decision Date March 09, 1994
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

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

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