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 Cemented Acetabular Component)
510(k) Number K854935
Device Name LINK METAL-BACKED ACETABULAR CUPS
Applicant
Link America, Inc.
C/O Surgical Implants, Inc.
10 Great Meadow Ln.
East Hanavor,  NJ  07936
Applicant Contact EDWARD B SCHUSSLER
Correspondent
Link America, Inc.
C/O Surgical Implants, Inc.
10 Great Meadow Ln.
East Hanavor,  NJ  07936
Correspondent Contact EDWARD B SCHUSSLER
Regulation Number888.3320
Classification Product Code
JDL  
Date Received12/10/1985
Decision Date 03/05/1986
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
-
-