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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K915617
Device Name LSF HA COATED FEMORAL HIP
Applicant
Implant Technology, Inc.
400 Plz. Dr.
Secaucus,  NJ  07094
Applicant Contact HOWARD MANN
Correspondent
Implant Technology, Inc.
400 Plz. Dr.
Secaucus,  NJ  07094
Correspondent Contact HOWARD MANN
Regulation Number888.3353
Classification Product Code
MEH  
Date Received12/16/1991
Decision Date 05/28/1992
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
-
-