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 K083033
Device Name VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
Applicant
Orthovita, Inc.
45 Great Valley Pkwy.
Malver,  PA  19355
Applicant Contact DEBORAH L JACKSON
Correspondent
Orthovita, Inc.
45 Great Valley Pkwy.
Malver,  PA  19355
Correspondent Contact DEBORAH L JACKSON
Regulation Number888.3045
Classification Product Code
MQV  
Date Received10/10/2008
Decision Date 11/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-