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 prosthesis, chin, internal
510(k) Number K191916
Device Name Stryker CMF MEDPOR Priority Customized Implant Kit
Applicant
Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
Freiburg,  DE D-79111
Applicant Contact Gregory Gohl
Correspondent
Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
Freiburg,  DE D-79111
Correspondent Contact Gregory Gohl
Regulation Number878.3550
Classification Product Code
FWP  
Date Received07/17/2019
Decision Date 08/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-