Cleared Traditional

CERCLAGE WIRE CRIMP BLOCK

K960651 · Acu Med, Inc. · Orthopedic
May 1996
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K960651 is an FDA 510(k) clearance for the CERCLAGE WIRE CRIMP BLOCK, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Acu Med, Inc. (Beaveton, US). The FDA issued a Cleared decision on May 3, 1996, 78 days after receiving the submission on February 15, 1996. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K960651 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1996
Decision Date May 03, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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

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