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 filler, bone void, calcium compound
510(k) Number K222063
Device Name MONTAGE Settable, Resorbable Bone Putty
Applicant
Orthocon, Inc.
1 Bridge Street - Suite 121
Irvington,  NY  10533
Applicant Contact Aniq Darr
Correspondent
Orthocon, Inc.
8 Lookout
Hilton Head Island,  SC  29928
Correspondent Contact Howard Schrayer
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
OIS  
Date Received07/13/2022
Decision Date 02/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-