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 K931572
Device Name LINK CERAMIC HEADS 14/16 X 32MM
Applicant
Link America, Inc.
321 Palmer Rd.
Denville,  NJ  07834
Applicant Contact JONATHAN MARTINEK
Correspondent
Link America, Inc.
321 Palmer Rd.
Denville,  NJ  07834
Correspondent Contact JONATHAN MARTINEK
Regulation Number888.3353
Classification Product Code
LZO  
Date Received03/30/1993
Decision Date 03/28/1994
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
-
-