Cleared Traditional

CHEMONUCLEOLYSIS TABLE EXTENSION

K831042 · Orthopedic Systems, Inc. · General & Plastic Surgery
May 1983
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K831042 is an FDA 510(k) clearance for the CHEMONUCLEOLYSIS TABLE EXTENSION, a Table, Operating-room, Manual (Class I — General Controls, product code FSE), submitted by Orthopedic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1983, 46 days after receiving the submission on March 31, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number K831042 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1983
Decision Date May 16, 1983
Days to Decision 46 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FSE — Table, Operating-room, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4950

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