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 neurological stereotaxic instrument
510(k) Number K081867
Device Name MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
Applicant
MAKO SURGICAL CORP.
2555 DAVIE RD.
FORT LAUDERDALE,  FL  33317
Applicant Contact WILLIAM TAPIA
Correspondent
MAKO SURGICAL CORP.
2555 DAVIE RD.
FORT LAUDERDALE,  FL  33317
Correspondent Contact WILLIAM TAPIA
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/01/2008
Decision Date 11/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-