FDA.reportPublic FDA data

AESCULAP IMPLANT SYSTEMS, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30056733112916714AESCULAP IMPLANT SYSTEMS, LLC1Y2020-04-253773 CORPORATE PWKY. CENTER VALLEY PA US 18034
30057260223003587896AESCULAP IMPLANT SYSTEMS, LLC1N2020-04-25615 Lambert Pointe Dr HAZELWOOD MO US 63042
30057396253005739625AESCULAP IMPLANT SYSTEMS, LLC1N2020-04-259999 HAMILTON BLVD., BLDG 8 Breinigsville PA US 18031

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
04038653399277SPECTRUM - SPECTRUM CERVICAL PLATE 4 HOLES 20MM+1(888)229-3002setworld_orders@aesculap.com
04038653399277SPECTRUM - SPECTRUM CERVICAL PLATE 4 HOLES 20MM+1(800)282-9000GUDID.BBMUS_Service@bbraun.com
04038653399284SPECTRUM - SPECTRUM CERVICAL PLATE 4 HOLES 22MM+1(888)229-3002setworld_orders@aesculap.com
04038653399284SPECTRUM - SPECTRUM CERVICAL PLATE 4 HOLES 22MM+1(800)282-9000GUDID.BBMUS_Service@bbraun.com
04038653399291SPECTRUM - SPECTRUM CERVICAL PLATE 4 HOLES 24MM+1(888)229-3002setworld_orders@aesculap.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
249541956886015P120024ACTIVL ARTIFICIAL DISCMJO2015-06-11
249551956886015P120024ACTIVL ARTIFICIAL DISCMJO2015-06-11
249541180997731K984124AESCULAP XENON LIGHT SOURCEFSS1999-02-01
249551180997731K984124AESCULAP XENON LIGHT SOURCEFSS1999-02-01
249551623311674K982914AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTSMNI1998-10-02
249541623311674K982914AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTSMNI1998-10-02
249541218996103K980686AESCULAP HILAN MOTOR SYSTEMHBB1998-09-02
249551218996103K980686AESCULAP HILAN MOTOR SYSTEMHBB1998-09-02
249541560758317K980484AESCULAP SPINE SYSTEM EVOLUTIONMNI1998-10-02
249551560758317K980484AESCULAP SPINE SYSTEM EVOLUTIONMNI1998-10-02
249541860362789K974706AESCULAP ABC CERVICAL PLATING SYSTEMKWQ1998-03-13
249551860362789K974706AESCULAP ABC CERVICAL PLATING SYSTEMKWQ1998-03-13
249541129654954K972332AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEMGXN1998-01-16
249551129654954K972332AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEMGXN1998-01-16
249541796751132K970549TITANIUM ALLOY BONE SCREWSHWC1997-04-30
249551796751132K970549TITANIUM ALLOY BONE SCREWSHWC1997-04-30
249541938164221K970541AESCULAP MODULAR MONOPOLAR ELECTRODESGEI1997-03-28
249551938164221K970541AESCULAP MODULAR MONOPOLAR ELECTRODESGEI1997-03-28
249551012854288K954652AESCULAP ENDOSCCOPIC SPINE INSTRUMENTSHRX1996-02-14
249541012854288K954652AESCULAP ENDOSCCOPIC SPINE INSTRUMENTSHRX1996-02-14
249541956641244K953720AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSIONKWQ1995-11-02
249551956641244K953720AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSIONKWQ1995-11-02
249541932001157K933330AESCULAP MANUAL ENDOSCOPIC INSTRUMENTSGCJ1994-06-07
249551932001157K933330AESCULAP MANUAL ENDOSCOPIC INSTRUMENTSGCJ1994-06-07
249541636307539K913765YASARGIL ANEURYSM CLIPS, MODIFICATIONHCH1992-03-11
249541819000344K913415AESCULAP TITANIUM BONE SCREWSHWC1991-10-29
249551819000344K913415AESCULAP TITANIUM BONE SCREWSHWC1991-10-29
249541585091059K880704CERULLO SUCTION REGULATORGCX1988-03-29
249551585091059K880704CERULLO SUCTION REGULATORGCX1988-03-29
249541608125471K833650YASARGIL STANDARD ANEURYSM CLIP &HCH1984-01-18
249541465928885K180914Aesculap Slim Clip ApplierHCI2018-04-17
665691465928885K180914Aesculap Slim Clip ApplierHCI2018-04-17
249551214631906K180433ENNOVATE®NKB2018-04-26
249541214631906K180433ENNOVATE®NKB2018-04-26
665691633885527K173271Aesculap Slim Clip Applier ForcepsHCI2017-11-10
249541633885527K173271Aesculap Slim Clip Applier ForcepsHCI2017-11-10
249551963762431K172850SterilContainer with PrimeLine Pro LidKCT2017-11-17
249541963762431K172850SterilContainer with PrimeLine Pro LidKCT2017-11-17
249551899317249K172235CoreHip® SystemLZO2018-03-28
249541899317249K172235CoreHip® SystemLZO2018-03-28
249551794142825K172032Modulift Vertebral Body Replacement (VBR) SystemPLR2017-11-20
249541794142825K172032Modulift Vertebral Body Replacement (VBR) SystemPLR2017-11-20
249551851117845K162134ENNOVATE Spinal SystemNKB2016-12-14
249541851117845K162134ENNOVATE Spinal SystemNKB2016-12-14
249552004672447K153629ArcadiusXP C Spinal SystemOVE2016-05-25
249542004672447K153629ArcadiusXP C Spinal SystemOVE2016-05-25
249551976423320K153396Aesculap OrthoPilot Next GenerationOLO2016-05-16
249541976423320K153396Aesculap OrthoPilot Next GenerationOLO2016-05-16
249541193571599K151056Aesculap T-Space PEEK and XP Spinal SystemMAX2015-08-13
249551193571599K151056Aesculap T-Space PEEK and XP Spinal SystemMAX2015-08-13
249541263957706K150062Excia Total Hip SystemLZO2015-02-09
249551263957706K150062Excia Total Hip SystemLZO2015-02-09
249542025063565K143443VEGA Knee System, Columbus Total Knee SystemJWH2015-03-25
249552025063565K143443VEGA Knee System, Columbus Total Knee SystemJWH2015-03-25
249541177851676K143106VEGA Knee SystemJWH2014-11-21
249551177851676K143106VEGA Knee SystemJWH2014-11-21
249551894526997K142707AIS Odontoid Fracture Fixation SystemHWC2014-12-19
249541894526997K142707AIS Odontoid Fracture Fixation SystemHWC2014-12-19
249541789845623K142150AIS MODULIFT VBR SYSTEMMQP2014-10-29
665691789845623K142150AIS MODULIFT VBR SYSTEMMQP2014-10-29
249541046739339K141694AESCULAP ORTHOPILOT NEXT GENERATIONOLO2015-02-24
249542069058460K140915EXCIA TOTAL HIP SYSTEMLZO2014-07-21
249552069058460K140915EXCIA TOTAL HIP SYSTEMLZO2014-07-21
249541300050392K140452VEGA KNEE SYSTEMJWH2014-03-25
249551300050392K140452VEGA KNEE SYSTEMJWH2014-03-25
249541244545894K133802AIS MODULIFT VBR SYSTEMMQP2014-04-17
249551244545894K133802AIS MODULIFT VBR SYSTEMMQP2014-04-17
249541690741311K132421AESCULAP PEEK XP SPINAL IMPLANT SYSTEMMAX2014-01-22
249551690741311K132421AESCULAP PEEK XP SPINAL IMPLANT SYSTEMMAX2014-01-22
249541585049217K131167UNIVATIONHRY2013-10-17
249551585049217K131167UNIVATIONHRY2013-10-17
249541728821238K130887S4C NAVIGATION INSTRUMENTSOLO2013-08-13
249551728821238K130887S4C NAVIGATION INSTRUMENTSOLO2013-08-13
249541502148670K130291S4 SPINAL SYSTEMNKB2013-04-11
249551502148670K130291S4 SPINAL SYSTEMNKB2013-04-11
249541694237923K123939S4 SPINAL SYSTEMNKB2013-03-12
249551694237923K123939S4 SPINAL SYSTEMNKB2013-03-12
249541373864191K123909AESCULAP CESPACE XPODP2013-04-15
249551373864191K123909AESCULAP CESPACE XPODP2013-04-15
249541472516403K123352S4 SPINAL SYSTEMNKB2012-12-12
249551472516403K123352S4 SPINAL SYSTEMNKB2012-12-12
249541744075975K122985COLUMBUS REVISION KNEE SYSTEMJWH2012-10-26
249551744075975K122985COLUMBUS REVISION KNEE SYSTEMJWH2012-10-26
249541026259167K122783PLASMAFIT ACETABULAR CUP AND VITELENE INSERTOQG2013-10-30
249551026259167K122783PLASMAFIT ACETABULAR CUP AND VITELENE INSERTOQG2013-10-30
665691918292323K121801QUINTEX CERVICAL PLATING SYSTEMKWQ2012-09-11
249541918292323K121801QUINTEX CERVICAL PLATING SYSTEMKWQ2012-09-11
249541122336997K120955COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEMJWH2012-12-17
249551122336997K120955COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEMJWH2012-12-17
249541910551861K112682METHA HIP SYSTEMLZO2012-03-19
249551910551861K112682METHA HIP SYSTEMLZO2012-03-19
249541981349913K112551S4 SPINAL SYSTEMNKB2011-11-21
249551981349913K112551S4 SPINAL SYSTEMNKB2011-11-21
249541545907933K111122AESCULAP SIBD XP SPINAL SYSTEMOVD2011-08-04
249551545907933K111122AESCULAP SIBD XP SPINAL SYSTEMOVD2011-08-04
249541845261744K110864BIOSPINE VBR SYSTEMMQP2011-06-15
249551845261744K110864BIOSPINE VBR SYSTEMMQP2011-06-15
249541923072605K103284LAMINOPLASY PLATING SYSTEMNQW2010-12-02
249551923072605K103284LAMINOPLASY PLATING SYSTEMNQW2010-12-02
249541566711017K102505HTO PLATING SYSTEMHRS2010-11-24
249551566711017K102505HTO PLATING SYSTEMHRS2010-11-24
249541061071114K101815ENDURO KNEE SYSTEMKRO2010-12-20
249551061071114K101815ENDURO KNEE SYSTEMKRO2010-12-20
249541678954605K101281VEGA KNEE SYSTEMJWH2010-07-30
249551678954605K101281VEGA KNEE SYSTEMJWH2010-07-30
249541482858283K100802AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEMOVD2010-07-20
249551482858283K100802AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEMOVD2010-07-20
249541792901644K100623AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEMNKB2010-06-09
249551792901644K100623AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEMNKB2010-06-09
249541401885994K100243QUINTEX CERVICAL PLATING SYSTEMKWQ2010-09-02
665691401885994K100243QUINTEX CERVICAL PLATING SYSTEMKWQ2010-09-02
249541329744242K100147S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEMNKB2010-07-23
249551329744242K100147S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEMNKB2010-07-23
249541405046587K092143EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEMMEH2009-09-22
249551405046587K092143EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEMMEH2009-09-22
249541671603783K090657MODIFICATION TO: S4 SPINAL SYSTEMNKB2009-04-20
249551671603783K090657MODIFICATION TO: S4 SPINAL SYSTEMNKB2009-04-20
249541172411295K090354LAMINOPLASTY PLATING SYSTEMNQW2009-05-12
249551172411295K090354LAMINOPLASTY PLATING SYSTEMNQW2009-05-12
249541431505468K090299BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADSLZO2009-04-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB272018-04-26
JWH262015-03-25
KWQ222012-09-11
LZO182018-03-28
MNI112006-02-03
MQP102014-10-29
MEH82009-09-22
MAX62015-08-13
HWC62014-12-19
OLO52016-05-16
HCI42018-04-17
HRY42013-10-17
ODP42013-04-15
OVD42011-08-04
NQW42010-12-02
HRS42010-11-24
LWJ42006-08-18
HAW42002-07-25
KWP42002-01-30
HRX42001-04-27
HCH32004-12-09
PLR22017-11-20
KCT22017-11-17
OVE22016-05-25
MJO22015-06-11
OQG22013-10-30
KRO22010-12-20
MAI22007-04-30
JDI22006-08-02
KWY22006-05-31
FRG22006-02-15
HBC22006-01-18
MQV22005-03-25
LPH22004-08-25
FSS21999-02-01
HBB21998-09-02
GXN21998-01-16
GEI21997-03-28
GCJ21994-06-07
GCX21988-03-29

PMA#

PMN#

GUDID#

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