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 Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K082088
Device Name MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II
Applicant
Mako Surgical Corp.
2555 Davie Rd.
Fort Lauderdale,  FL  33317
Applicant Contact WILLIAM F TAPIA
Correspondent
Mako Surgical Corp.
2555 Davie Rd.
Fort Lauderdale,  FL  33317
Correspondent Contact WILLIAM F TAPIA
Regulation Number888.3540
Classification Product Code
KRR  
Date Received07/24/2008
Decision Date 10/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-