Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Orthopedic Computer Controlled Surgical System
510(k) Number K072629
FOIA Releasable 510(k) K072629
Device Name DIGIMATCH ROBODOC SURGICAL SYSTEM
Applicant
INTEGRATED SURGICAL SYSTEMS, INC.
1433 N. MARKET BLVD., #1
SACREMENTO,  CA  95834
Applicant Contact RUSS HIBBERT
Correspondent
INTEGRATED SURGICAL SYSTEMS, INC.
1433 N. MARKET BLVD., #1
SACREMENTO,  CA  95834
Correspondent Contact RUSS HIBBERT
Regulation Number882.4560
Classification Product Code
OJP  
Subsequent Product Code
HAW  
Date Received09/17/2007
Decision Date 08/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-