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 stereotaxic instrument
510(k) Number K121765
Device Name SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
Applicant
STANMORE IMPLANTS WORLDWIDE LTD
1331 H STREET, NW, 12 FLOOR
WASHINGTON,  DC  20005
Applicant Contact HOLLACE SAAS RHODES
Correspondent
STANMORE IMPLANTS WORLDWIDE LTD
1331 H STREET, NW, 12 FLOOR
WASHINGTON,  DC  20005
Correspondent Contact HOLLACE SAAS RHODES
Regulation Number882.4560
Classification Product Code
OLO  
Date Received06/15/2012
Decision Date 01/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-