Cleared Traditional

K883457 - ASST-3000 SPINAL SURGERY TABLE
(FDA 510(k) Clearance)

K883457 · Orthopedic Systems, Inc. · General & Plastic Surgery device

Aug 1988

Decision

14d

Days

Class 1

Risk

K883457 is an FDA 510(k) clearance for the ASST-3000 SPINAL SURGERY TABLE. This device is classified as a Table, Operating-room, Non-electrical (Class I - General Controls, product code FWY).

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on August 26, 1988, 14 days after receiving the submission on August 12, 1988.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number	K883457 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 12, 1988
Decision Date	August 26, 1988
Days to Decision	14 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—