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 Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
510(k) Number K094035
Device Name EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
Applicant
Stelkast Company
200 Hidden Valley Rd.
Mcmurray,  PA  15317
Applicant Contact DONALD A STEVENS
Correspondent
Stelkast Company
200 Hidden Valley Rd.
Mcmurray,  PA  15317
Correspondent Contact DONALD A STEVENS
Regulation Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
JDI   LPH   LWJ   LZO   MAY  
OQH   OQI  
Date Received12/30/2009
Decision Date 03/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-