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 Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
510(k) Number K122158
FOIA Releasable 510(k) K122158
Device Name PBP TOTAL HIP SYSTEM
Applicant
Pipeline Biomedical Products, LLC
901 King St., Suite 200
Alexandria,  VA  22314
Applicant Contact TERRY POWELL
Correspondent
Pipeline Biomedical Products, LLC
901 King St., Suite 200
Alexandria,  VA  22314
Correspondent Contact TERRY POWELL
Regulation Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
JDI   LPH   LZO   MEH   OQH  
OQI  
Date Received07/20/2012
Decision Date 12/11/2012
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
-
-