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, bone
510(k) Number K030069
Device Name SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI,  PA  19301
Applicant Contact BONNIE J SMITH
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI,  PA  19301
Correspondent Contact BONNIE J SMITH
Regulation Number872.4760
Classification Product Code
JEY  
Date Received01/08/2003
Decision Date 04/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-