FDA.reportPublic FDA data

OSTEOTECH, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22499153002600221OSTEOTECH, INC.1N2026-01-01201 Industrial Way West EATONTOWN NJ US 07724

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1353351332459093K151543Graft Delivery Device with Integrated StyletFMF2015-07-07
1353351320990027K122513CLEARED UNDER GRAFTON II EDBMMBP2013-03-06
1353351451284679K082615GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICESMQV2008-10-16
1353351720678640K081227PLEXUR MMQV2008-07-22
1353351669810962K080511PLEXUR-PMQV2008-04-21
1353351336303414K073405PLEXUR MMQV2008-03-03
1353351865803992K061982PLEXUR PMBP2007-02-07
1353351992208888K053098OPTIUM DBM GEL AND PUTTYMBP2005-11-28
1353351732490980K051195GRAFTON DBMMBP2005-12-16
1353351342724318K051188GRAFTON DBMNUN2006-01-03
1353352023798634K043048GRAFTON PLUS DBM PASTEMBP2005-11-23
1353351413231190K042707GRAFTON PLUS DBM PASTENUN2005-11-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBP52013-03-06
MQV42008-10-16
NUN22006-01-03
FMF12015-07-07

PMN#

VBR

2001-10-16

OSTEOTECH, INC.