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 K193128
Device Name Mako Total Hip Application
Applicant
Mako Surgical Corp.
2555 Davie Rd.
Fort Lauderdale,  FL  33317
Applicant Contact Liza Gordillo
Correspondent
Mako Surgical Corp.
2555 Davie Rd.
Fort Lauderdale,  FL  33317
Correspondent Contact Liza Gordillo
Regulation Number882.4560
Classification Product Code
OLO  
Date Received11/12/2019
Decision Date 02/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-