Cleared Traditional

K ORTHOPEDIC TABLE

K881101 · Instrumentation Specialties, Inc. · General & Plastic Surgery

Apr 1988

Decision

22d

Days

Class 1

Risk

About This 510(k) Submission

K881101 is an FDA 510(k) clearance for the K ORTHOPEDIC TABLE, a Table, Surgical With Orthopedic Accessories, Manual (Class I — General Controls, product code JEB), submitted by Instrumentation Specialties, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 6, 1988, 22 days after receiving the submission on March 15, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number	K881101 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 1988
Decision Date	April 06, 1988
Days to Decision	22 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—