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 Cerclage, Fixation
510(k) Number K161876
Device Name Tritium® Sternal Cable Plate System
Applicant
Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
375 River Park Cir.
Marquette,  MI  49855
Applicant Contact Sarah Pleaugh
Correspondent
Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact Sarah Pleaugh
Regulation Number888.3010
Classification Product Code
JDQ  
Subsequent Product Codes
HRS   HWC  
Date Received07/08/2016
Decision Date 09/09/2016
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
-
-