Cleared Traditional

BRITISH SPINAL FUSION SET

K842698 · Downs Surgical , Ltd. · General & Plastic Surgery
Sep 1984
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K842698 is an FDA 510(k) clearance for the BRITISH SPINAL FUSION SET, a Guide, Surgical, Instrument (Class I — General Controls, product code FZX), submitted by Downs Surgical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1984, 63 days after receiving the submission on July 11, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K842698 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1984
Decision Date September 12, 1984
Days to Decision 63 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FZX — Guide, Surgical, Instrument
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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