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 K121064
Device Name MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
Applicant
MAKO SURGICAL CORPORATION
2555 DAVIE ROAD
FORT LAUDERDALE,  FL  33317
Applicant Contact DIONNE SANDERS
Correspondent
MAKO SURGICAL CORPORATION
2555 DAVIE ROAD
FORT LAUDERDALE,  FL  33317
Correspondent Contact DIONNE SANDERS
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/06/2012
Decision Date 06/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-