Cleared Traditional

COMPACT COTREL -- DUBOUSSET SPINE SYSTEM

K921767 · Buckman Co., Inc. · Orthopedic
Jun 1993
Decision
434d
Days
Class 2
Risk

About This 510(k) Submission

K921767 is an FDA 510(k) clearance for the COMPACT COTREL -- DUBOUSSET SPINE SYSTEM, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on June 22, 1993, 434 days after receiving the submission on April 14, 1992. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K921767 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1992
Decision Date June 22, 1993
Days to Decision 434 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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