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, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K153216
Device Name Alpine Cemented Hip System
Applicant
Ortho Development Corporation
12187 S. Business Park Dr.
Draper,  UT  84020
Applicant Contact Drew Weaver
Correspondent
Ortho Development Corporation
12187 S. Business Park Dr.
Draper,  UT  84020
Correspondent Contact Drew Weaver
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KWL   KWY   LPH   LZO   MBL  
Date Received11/05/2015
Decision Date 02/18/2016
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
-
-