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 K142295
Device Name Sirius Femoral Stem, Size 30A
Applicant
Biomet, Inc.
56 East Bell Drive
Warsaw,  IN  46581
Applicant Contact Jason Dugger
Correspondent
Biomet, Inc.
56 East Bell Drive
Warsaw,  IN  46581
Correspondent Contact Jason Dugger
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
JDG   KWL   KWY   KWZ   LPH  
LZO   LZY   MEH   OQG   OQH   OQI  
PBI  
Date Received08/18/2014
Decision Date 09/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-