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 Thoracolumbosacral Pedicle Screw System
510(k) Number K103287
Device Name SYNTHES 6.0 COCR AND CPT TI-3 RODS
Applicant
SYNTHES SPINE
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact ELIZABETH KIERZEK
Correspondent
SYNTHES SPINE
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact ELIZABETH KIERZEK
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received11/01/2010
Decision Date 01/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-