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 Wax, Bone
510(k) Number K191140
Device Name MONTAGE-QS Settable, Resorbable Hemostatic Bone
Applicant
Orthocon, Inc.
1 Bridge St., Suite 121
Irvington,  NY  10533
Applicant Contact Howard L. Schrayer
Correspondent
Orthocon, Inc.
1 Bridge St., Suite 121
Irvington,  NY  10533
Correspondent Contact Howard L. Schrayer
Classification Product Code
MTJ  
Date Received04/30/2019
Decision Date 07/18/2019
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-