FDA.reportPublic FDA data

ETEX Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12251123000206397ETEX Corporation1N2026-01-0155 Messina Dr Braintree MA US 02184

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00889024205444AccuFill® - 201.050+1(877)383-9276sales@etexcorp.com
00889024205567CarriGen ® - 76-6036877-383-9276sales@etexcorp.com
00889024406476AccuFill® - 201.030+1(877)383-9276sales@etexcorp.com
00889024432826CarriGen - 76-6035877-383-9276sales@etexcorp.com
00889024563278N-Force Blue ™ - IN050-718003489500customerservice@zimmerbiomet.com
00889024563285N-Force Blue ™ - IN050-818003489500customerservice@zimmerbiomet.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
727781278447664K983009BSM- BONE SUBSTITUTE MATERIALGXP1998-11-25
727781509570938K962548BSM BONE SUBSTITUTE MATERIAL KITLYC1997-08-05
727781623319877K190814AccuFill Bone Substitute MaterialMQV2019-06-10
727781321235191K182107CarriGen PFMQV2018-08-31
727781278951368K141245ETEX MIXING AND DELIVERY SYSTEMFMF2014-07-09
727781591472998K102812GAMMA-BSM; BETA-BSM; EQUIVABONELYC2010-12-03
727781451680667K101557GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGENMQV2010-07-01
727781391322783K093447CARRIGENMQV2010-02-18
727781310360197K091729ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONELYC2009-12-23
727781378875369K090855EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTEMQV2009-09-18
727781855766815K090310EQUIVABONEMQV2009-03-24
727781075914191K080329CAP PLUS, EQUIVABONE, CAP/DBMMBP2008-04-28
727781773841250K072636A-BSM BONE SUBSTITUTE MATERIALMQV2007-10-23
727781280467799K072355OSSIFUSE BONE SUBSTITUTE MATERIALMQV2007-09-26
727781048038711K063050CAP PLUSMQV2007-11-19
727781233119610K032307CAP BONE SUBSTITUTE MATERIALGXP2003-10-24
727781048038711
727781148985614
727781166235789
727781321235191
727781378875369
727781451991576
727781509570938
727781765915079
727781855766815
727782010612752

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQV92019-06-10
LYC32010-12-03
GXP22003-10-24
FMF12014-07-09
MBP12008-04-28

PMN#

GUDID#