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, Porous Uncemented
510(k) Number K151440
Device Name Klassic HD Hip System
Applicant
Total Joint Orthopedics, Inc.
1567 E. Stratford Ave.
Salt Lake City,  UT  84106
Applicant Contact CHRIS WEABER
Correspondent
Total Joint Orthopedics, Inc.
1567 E. Stratford Ave.
Salt Lake City,  UT  84106
Correspondent Contact CHRIS WEABER
Regulation Number888.3358
Classification Product Code
LPH  
Date Received05/29/2015
Decision Date 09/03/2015
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
-
-