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, Cemented
510(k) Number K955296
Device Name LINK MP RECONSTRUCTION HIP
Applicant
Link America, Inc.
6060 Castleway Dr.
Suite 236
Indianapolis,  IN  46250
Applicant Contact DOUGLAS W STUART
Correspondent
Link America, Inc.
6060 Castleway Dr.
Suite 236
Indianapolis,  IN  46250
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
LWJ   LZO  
Date Received11/16/1995
Decision Date 02/14/1996
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
Recalls CDRH Recalls
-
-