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DEPUY CMW

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96109213002806724DEPUY CMW1N2026-01-01CORNFORD RD. BLACKPOOL, LANCASHIRE Lancashire GB FY4 4QQ

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
38251557871379P960001DEPUY 1 BONE CEMENTLOD1997-02-11
38251491511371K943727BIOSTOP G BONE CEMENT RESTRICTORLZN1995-05-11
38251035581259K873689CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIALGXP1987-10-26
38251191188700K873688ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIALJXH1987-10-26
38251697222625K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementKWL2026-05-15
38251129025046K141385DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)HBW2015-03-27
38251039529312K112907CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20GNDN2011-12-22
38251335932668K081163SMARTSET GMV GENTAMICIN BONE CEMENTMBB2008-05-14
38251555432722K081155SMARTSET MV BONE CEMENTLOD2008-05-14
38251967471077K073115ORTHOMESHHRS2008-07-15
38251175367255K071927MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENTNDN2007-11-21
38251118152687K071791MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280GXP2007-07-30
38251591284493K071776ANEUROPLASTIC, MODEL 43-1290JXH2007-07-26
38251096742506K062789SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEMJEY2007-02-27
38251921549294K061144DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENTMBB2006-06-08
38251169292206K053445SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENTLOD2006-01-06
38251216939045K053022SYNTHES (USA) CHRONOS-BETA-TCPLYC2006-01-23
38252045365682K053003DEPUY CMW 1, 2 AND 3 BONE CEMENTSLOD2005-11-22
38251913446617K053002DEPUY CMW 1 GENTAMICIN BONE CEMENTMBB2005-11-22
38251088108237K043406VERTEBROPLASTIC RADIOPAQUE BONE CEMENTNDN2005-07-15
38251946152407K042591SMARTMIX PRE-FILLED MIXING SYSTEMKIH2004-10-22
38251852583203K041656MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENTLOD2004-07-01
38251145555075K041611SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMPGXR2004-09-08
38251485812550K041350SYNTHES (USA) CHRONOSGXP2004-07-08
38251341079843K033563SMARTSET GHV GENTAMICIN BONE CEMENTLOD2004-02-05
38251885347714K033382SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENTLOD2004-02-05
38251766675514K030069SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEMJEY2003-04-08
38251981832239K023103DEPUY 1 GENTAMICIN BONE CEMENTLOD2003-09-29
38251544046619K023012SMARTSET HV BONE CEMENTLOD2003-02-13
38251782731637K021499CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENTLOD2002-07-24
38251555708706K014053CONDUIT TCP GRANULESMQV2002-03-08
38251190570014
38251424947010
38251756675271

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOD92008-05-14
NDN32011-12-22
MBB32008-05-14
GXP32007-07-30
JXH22007-07-26
JEY22007-02-27
KWL12026-05-15
HBW12015-03-27
HRS12008-07-15
LYC12006-01-23
KIH12004-10-22
GXR12004-09-08
MQV12002-03-08
LZN11995-05-11