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 K183113
Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional
Applicant
Synthes (USA) Products LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Rebecca Reiter
Correspondent
Synthes (USA) Products LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Rebecca Reiter
Regulation Number872.4760
Classification Product Code
MQN  
Subsequent Product Codes
DZK   DZL   NEI   OAT  
Date Received11/09/2018
Decision Date 03/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-