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

Premarket Approval (PMA)
  • 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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES
Generic NameFiller, bone void, non-osteoinduction
ApplicantInterpore Intl.
181 Technology Dr.
Irvine, CA 92618
PMA NumberP860005
Supplement NumberS011
Date Received04/22/1999
Decision Date05/25/1999
Reclassified Date06/02/2003
Product Codes LMN MBS 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updated labeling that reflects the results of the completed post-market approval study.
-
-