Cleared Traditional

ANTERIOR SPINE SYSTEM

K934429 · Buckman Co., Inc. · Orthopedic
Oct 1994
Decision
402d
Days
Class 2
Risk

About This 510(k) Submission

K934429 is an FDA 510(k) clearance for the ANTERIOR SPINE SYSTEM, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on October 20, 1994, 402 days after receiving the submission on September 13, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K934429 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1993
Decision Date October 20, 1994
Days to Decision 402 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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