Cleared Traditional

ORTHO-J, INC. BEK-JS-004

K891917 · Ortho-J, Inc. · General & Plastic Surgery

May 1989

Decision

60d

Days

Class 1

Risk

About This 510(k) Submission

K891917 is an FDA 510(k) clearance for the ORTHO-J, INC. BEK-JS-004, a Table, Surgical With Orthopedic Accessories, Manual (Class I — General Controls, product code JEB), submitted by Ortho-J, Inc. (Tifton, US). The FDA issued a Cleared decision on May 26, 1989, 60 days after receiving the submission on March 27, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number	K891917 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 1989
Decision Date	May 26, 1989
Days to Decision	60 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—