DIGIMATCH ROBODOC SURGICAL SYSTEM— 510(k) K072629

Name: FDA 510(k) clearance K072629
Creator: U.S. Food and Drug Administration
Published: 2008-08-06

Substantially Equivalent

Integrated Surgical Systems, Inc.

FDA 510(k) clearance K072629 for DIGIMATCH ROBODOC SURGICAL SYSTEM, Substantially Equivalent on 2008-08-06. Applicant: Integrated Surgical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Integrated Surgical Systems, Inc.
Product code: Code OJP
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2007-09-17
Decision date: 2008-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacremento, CA, US

Download summary PDF View on FDA.gov ↗

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