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 Condylar Plate Fixation Implant
510(k) Number K110354
Device Name 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
Applicant
Synthes USA
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact THOMAS N SHEA
Correspondent
Synthes USA
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact THOMAS N SHEA
Regulation Number888.3030
Classification Product Code
JDP  
Subsequent Product Codes
HRS   HWC  
Date Received02/07/2011
Decision Date 03/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-