Cleared Traditional

ELEVATOR, COBB SPINAL

K870591 · Military Engineering, Inc. · General & Plastic Surgery
Feb 1987
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K870591 is an FDA 510(k) clearance for the ELEVATOR, COBB SPINAL, a Elevator, Surgical, General & Plastic Surgery (Class I — General Controls, product code GEG), submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on February 26, 1987, 16 days after receiving the submission on February 10, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K870591 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1987
Decision Date February 26, 1987
Days to Decision 16 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GEG — Elevator, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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