Cleared Traditional

ORTHODOC PREOPERATIVE PLANNER MODEL 500

K960685 · Integrated Surgical Systems, Inc. · Orthopedic

Jan 1997

Decision

332d

Days

Class 1

Risk

About This 510(k) Submission

K960685 is an FDA 510(k) clearance for the ORTHODOC PREOPERATIVE PLANNER MODEL 500, a Template (Class I — General Controls, product code HWT), submitted by Integrated Surgical Systems, Inc. (Sacramento, US). The FDA issued a Cleared decision on January 17, 1997, 332 days after receiving the submission on February 20, 1996. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4800.

Submission Details

510(k) Number	K960685 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 20, 1996
Decision Date	January 17, 1997
Days to Decision	332 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF