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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K935452
Device Name P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
Applicant
JOHNSON & JOHNSON ORTHOPAEDICS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact MARSHA J STONE
Correspondent
JOHNSON & JOHNSON ORTHOPAEDICS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact MARSHA J STONE
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
LPH  
Date Received11/12/1993
Decision Date 10/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-