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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name screw, fixation, intraosseous
510(K) Number K021850
Device Name SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS
Applicant
SYNTHES (USA)
1690 russell rd.
paoli,  PA  19301
Contact matthew m hull
Regulation Number872.4880
Classification Product Code
DZL  
Date Received06/05/2002
Decision Date 06/10/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-