Cleared Traditional

OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION)

K881060 · Orthopedic Systems, Inc. · General & Plastic Surgery
Mar 1988
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K881060 is an FDA 510(k) clearance for the OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION), a Table, Surgical With Orthopedic Accessories, Ac-powered (Class I — General Controls, product code JEA), submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on March 25, 1988, 21 days after receiving the submission on March 4, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K881060 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 1988
Decision Date March 25, 1988
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code JEA — Table, Surgical With Orthopedic Accessories, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960

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