Cleared Traditional

DIGIMATCH ROBODOC SURGICAL SYSTEM

K072629 · Integrated Surgical Systems, Inc. · Orthopedic
Aug 2008
Decision
324d
Days
Class 2
Risk

About This 510(k) Submission

K072629 is an FDA 510(k) clearance for the DIGIMATCH ROBODOC SURGICAL SYSTEM, a Orthopedic Computer Controlled Surgical System (Class II — Special Controls, product code OJP), submitted by Integrated Surgical Systems, Inc. (Sacremento, US). The FDA issued a Cleared decision on August 6, 2008, 324 days after receiving the submission on September 17, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K072629 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2007
Decision Date August 06, 2008
Days to Decision 324 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OJP — Orthopedic Computer Controlled Surgical System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560
Definition Pre-operative Planning And Intra-operative Execution Of Surgical Movements With Robotically Controlled End Effectors Under User Supervision. Alternative To Manual Planning And Broaching/reaming Techniques For Femoral Canal Preparation In Primary Total Hip Arthroplasty (tha).