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 Plate, Fixation, Bone
510(k) Number K162974
Device Name Biomet Microfixation RibFix Blu Thoracic Fixation System
Applicant
Biomet Microfixation
1520 Tradeport Dr.
Jacksonville,  FL  32218
Applicant Contact Lauren Jasper
Correspondent
Biomet Microfixation
1520 Tradeport Dr.
Jacksonville,  FL  32218
Correspondent Contact Lauren Jasper
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received10/25/2016
Decision Date 12/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-