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 External Mandibular Fixator And/Or Distractor
510(k) Number K080153
Device Name SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM
Applicant
Synthes (Usa)
1301 Goshen Pkwy.
West Chester,  PA  19380
Applicant Contact ANDREA M TASKER
Correspondent
Synthes (Usa)
1301 Goshen Pkwy.
West Chester,  PA  19380
Correspondent Contact ANDREA M TASKER
Regulation Number872.4760
Classification Product Code
MQN  
Date Received01/23/2008
Decision Date 05/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-