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 K133785
Device Name TRITIUM STERNAL CABLE PLATE SYSTEM
Applicant
PIONEER SURGICAL TECHNOLOGY, INC
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855
Applicant Contact EMILY DOWNS
Correspondent
PIONEER SURGICAL TECHNOLOGY, INC
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855
Correspondent Contact EMILY DOWNS
Regulation Number888.3010
Classification Product Code
JDQ  
Subsequent Product Codes
HRS   HWC  
Date Received12/12/2013
Decision Date 01/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-