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, osteoinduction (w/o human growth factor)
510(k) Number K130498
Device Name OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
Applicant
BACTERIN INTERNATIONAL INC.
600 CRUISER LN.
BELGRADE,  MT  59714
Applicant Contact HOWARD L SCHRAYER
Correspondent
BACTERIN INTERNATIONAL INC.
600 CRUISER LN.
BELGRADE,  MT  59714
Correspondent Contact HOWARD L SCHRAYER
Regulation Number888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received02/26/2013
Decision Date 05/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-