Ascension Orthopedics, Inc.

Matched from indexed company URL: ASCENSION ORTHOPEDICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30142072833002788818Ascension Orthopedics, Inc.1N2026-01-0111101 Metric Blvd Austin TX US 78758
30142072833002788818Ascension Orthopedics, Inc.1N2020-04-2511101 Metric Blvd Austin TX US 78758

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
10381780240204Cadence™ - Cadence Talar Chamfer Cut Guide is secured on the talus bone to house the Talar Chamfer Reamer Guide for precise depth of holes drilled.+1(800)654-2873custsvcnj@integralife.com
10381780240211Cadence™ - Cadence Tibial Cut Guide is used to provide precise cutting of the tibia bone and can be used to provide an initial assessment of the correct tibial implant size to be used.+1(800)654-2873custsvcnj@integralife.com
10381780240228Cadence™ - Cadence Tibial Cut Guide is used to provide precise cutting of the tibia bone and can be used to provide an initial assessment of the correct tibial implant size to be used.+1(800)654-2873custsvcnj@integralife.com
10381780240235Cadence™ - Cadence Talar Cut Guide is used in making a precise cut of the Talus bone during resectioning.+1(800)654-2873custsvcnj@integralife.com
10381780240242Cadence™ - Cadence Talar Cut Guide is used in making a precise cut of the Talus bone during resectioning.+1(800)654-2873custsvcnj@integralife.com
10381780240754Cadence™ - Cadence 2mm Tibial Cut Guide is used to provide precise cutting of the tibia bone+1(800)654-2873custsvcnj@integralife.com
10381780245612Titan™ - Titan™ Reverse Shoulder System The IM head cutting guide is used during implant head resection.+1(800)654-2873custsvcnj@integralife.com
10381780246374Integra® - PyroCarbon PIP Total Joint PIP Vertical Cut Guide+1(800)654-2873custsvcnj@integralife.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2898961169152067P000057ASCENSION MCPNEG2001-11-19
2135571965663980P000057ASCENSION MCPNEG2001-11-19
2898961703509773K991873KMI WRIST FUSION SYSTEMHRS1999-08-17
2135571403741746K981194FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANTKWH1998-06-30
2898961906776820K981194FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANTKWH1998-06-30
2898961889910595K960692SUBTALAR MBA SYSTEMHWC1996-07-23
2898961131537267K233674Freedom Wrist Arthroplasty SystemJWJ2024-05-30
2898961033450678K233670Ascension Silicone MCP; Ascension Silicone PIPKYJ2023-12-14
2898961026132831K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)KWS2022-03-11
2898961758621374K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS SystemHRS2021-07-27
2898961478604026K201507Cadence Total Ankle SystemHSN2020-06-29
2898961186706365K190588Integra TITAN Reverse Shoulder SystemPHX2019-12-02
2135571272811306K190588Integra TITAN Reverse Shoulder SystemPHX2019-12-02
2898961026726090K182878Integra Salto Total Ankle SystemHSN2018-12-18
2135571242311796K182878Integra Salto Total Ankle SystemHSN2018-12-18
2898961493285743K181999Integra TITAN Reverse Shoulder SystemPHX2018-10-12
2135571619888422K181999Integra TITAN Reverse Shoulder SystemPHX2018-10-12
2898961714795152K181639Panta 2 Arthrodesis Nail SystemHSB2018-11-02
2135571808008842K181639Panta 2 Arthrodesis Nail SystemHSB2018-11-02
2898961736726425K173717Integra TITAN Reverse Shoulder SystemPHX2018-06-21
2135572024976445K173717Integra TITAN Reverse Shoulder SystemPHX2018-06-21
2135571483429082K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemHWC2017-07-14
2898961908485026K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemHWC2017-07-14
2898961349538241K161189Integra TITAN Reverse Shoulder SystemPHX2016-08-25
2135571585985245K161189Integra TITAN Reverse Shoulder SystemPHX2016-08-25
2135571681628782K160830Integra External Fixation SystemKTT2016-07-06
2135571928321842K153452Salto XT, Salto TalarisHSN2016-08-11
2898962034076051K153452Salto XT, Salto TalarisHSN2016-08-11
2135571456028240K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemHWC2015-10-29
2898961486026197K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemHWC2015-10-29
2135571848949964K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidKWS2015-12-23
2898962007606994K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidKWS2015-12-23
2135571697995180K151459Integra Total Ankle Replacement SystemHSN2015-08-31
2898961789344703K151459Integra Total Ankle Replacement SystemHSN2015-08-31
2898961651855583K142413TITAN Modular Total Shoulder SystemKWS2014-11-14
2135571865193679K142413TITAN Modular Total Shoulder SystemKWS2014-11-14
2135571982722991K140463INTEGRA EXTERNAL FIXATION SYSTEMKTT2014-10-10
2898961895283587K132250INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEMJWJ2014-03-24
2135571795845811K131360INTEGRA TITANIUM BONE WEDGEHRS2013-08-07
2135572041718596K130533SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHSHSN2013-05-17
2898962049422236K130533SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHSHSN2013-05-17
2898961372522585K130050TITAN REVERSE SHOULDER SYSTEMKWS2013-06-18
2135572048917324K130050TITAN REVERSE SHOULDER SYSTEMKWS2013-06-18
2135571771705513K123926METASURG NITINOL STAPLE IMPLANTJDR2013-05-03
2898962041074845K123926METASURG NITINOL STAPLE IMPLANTJDR2013-05-03
2135571436591081K123000INTEGRA TOTAL FOOT SYSTEMSHRS2012-12-21
2135571041155541K121826INTEGRA PROXIMAL HUMERAL PLATE SYSTEMHRS2013-02-13
2898961894011739K121826INTEGRA PROXIMAL HUMERAL PLATE SYSTEMHRS2013-02-13
2135571470683421K112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTKXE2012-04-09
2898961752195164K112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTKXE2012-04-09
2135571329771388K112438TITAN MODULAR TOTAL SHOULDER SYSTEMKWS2012-04-11
2898962053993465K112438TITAN MODULAR TOTAL SHOULDER SYSTEMKWS2012-04-11
2135571187099333K112278ASCENSION NUGRIP CMC IMPLANTKYI2011-11-04
2898961198925704K112278ASCENSION NUGRIP CMC IMPLANTKYI2011-11-04
2135571188077911K111799NUGAIT(TM) SUBTALAR IMPLANT SYSTEMHWC2011-08-19
2898961512793395K111536METASURG DIGIFUSE IMPLANTHWC2011-07-21
2135571620554043K111536METASURG DIGIFUSE IMPLANTHWC2011-07-21
2135571256600969K111265METASURG SUBTALAR IMPLANTHWC2011-08-09
2135571792649492K110700ASCENSION ATLAS HUMERAL PLATING SYSTEMHRS2011-12-06
2135571103372107K102549THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTYLZJ2010-12-21
2898961191075694K102549THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTYLZJ2010-12-21
2135571250630272K100502ASCENSION TOTAL PLATE SYSTEMHRS2010-08-02
2898961062951687K100448ASCENSION MODULAR TOTAL SHOULDER SYSTEMKWS2010-08-30
2135571558305249K100448ASCENSION MODULAR TOTAL SHOULDER SYSTEMKWS2010-08-30
2135571940427408K100176ASCENSION ANKLE FUSION PLATE SYSTEMHRS2010-06-16
2898961855789675K093914NEWDEAL COMPRESSION PLATESHRS2011-04-14
2898961619814682K093163INTEGRA TOTAL WRIST FUSION SYSTEMHRS2009-12-15
2135571601183372K092440ASCENSION CANNULATED SCREW SYSTEMHWC2009-11-05
2898961880372739K092440ASCENSION CANNULATED SCREW SYSTEMHWC2009-11-05
2135571370365762K092047ASCENSION METAL GREAT TOE SYSTEMKWD2010-01-14
2898962058113878K092047ASCENSION METAL GREAT TOE SYSTEMKWD2010-01-14
2898961325223453K091609NEWDEAL COMPRESSION PLATEHRS2009-06-30
2898961696672237K090076SALTO TALARIS TOTAL ANKLE PROSTHESISHSN2009-03-17
2135571969042513K090076SALTO TALARIS TOTAL ANKLE PROSTHESISHSN2009-03-17
2898961280461980K083469METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000KWD2009-02-13
2135571774427652K083469METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000KWD2009-02-13
2898962046633690K083154NEWDEAL HALLU LOCK PLATE SYSTEMHRS2009-07-10
2135571262322214K082231ASCENSION SILICONE PIPKYJ2009-01-12
2898961756814934K082231ASCENSION SILICONE PIPKYJ2009-01-12
2135571586934267K080997ASCENSION PYROCARBON LUNATEKWN2008-06-17
2898961874596609K080997ASCENSION PYROCARBON LUNATEKWN2008-06-17
2898961691378832K073375NEWDEAL TIBIAXYS SYSTEMHRS2008-02-21
2898961136679896K071639QWIX POSITIONING SCREWHWC2007-07-09
2898961556087895K071064ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HAHSD2007-06-22
2135572007246921K071064ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HAHSD2007-06-22
2898961470770315K070447NEWDEAL COMPRESSION PLATEHRS2007-03-29
2898961078637200K062861ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEMHSD2006-10-31
2135571414792314K062861ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEMHSD2006-10-31
2135571653703440K060560ASCENSION PYROSPHERE CMC/TMTKWD2006-05-05
2135571658999289K060544SALTO TALARIS TOTAL ANKLE PROSTHESISHSN2006-11-13
2898961699638393K060544SALTO TALARIS TOTAL ANKLE PROSTHESISHSN2006-11-13
2135571676504657K060026KOBY SURGICAL INTERNAL FIXATION SYSTEMHWC2006-01-26
2898962045764090K060026KOBY SURGICAL INTERNAL FIXATION SYSTEMHWC2006-01-26
2135571045329537K052137ASCENSION MUHKXE2005-11-03
2898961428189113K052137ASCENSION MUHKXE2005-11-03
2898961571066337K051611MBARESORB IMPLANTHWC2005-09-06
2898961116476529K050346STABILIZATION SCREWHWC2005-03-17
2135571258369087K042690ASCENSION PYROSPHERE (PCS)KYI2004-11-13
2898961975491228K042690ASCENSION PYROSPHERE (PCS)KYI2004-11-13
2135571354033040K041451ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50KYI2004-08-25
2898961642609351K032806KATALYST RADIAL HEAD IMPLANTKWI2004-04-16
2898961034240513K032686ASCENSION MODULAR RADIAL HEADKWI2003-10-22
2135571222021587K032686ASCENSION MODULAR RADIAL HEADKWI2003-10-22
2898961104057699K030037UNIVERSAL TOTAL WRIST SYSTEMJWJ2003-02-05
2135571196380815K023562MODIFICATION TO CLASSIC GREAT TOE IMPLANTKWH2002-11-13
2898961222733735K023562MODIFICATION TO CLASSIC GREAT TOE IMPLANTKWH2002-11-13
2135571187717689K023531LESSER METATARSAL PHALANGEAL JOINT IMPLANTKWH2003-01-17
2898962027613110K023531LESSER METATARSAL PHALANGEAL JOINT IMPLANTKWH2003-01-17
2135571153351953K023086CLASSIC GREAT TOE IMPLANTKWH2002-10-04
2898962032187734K023086CLASSIC GREAT TOE IMPLANTKWH2002-10-04
2135571143454777K022892ASCENSION SILLICONE MCPKYJ2002-11-25
2898962038868731K022892ASCENSION SILLICONE MCPKYJ2002-11-25
2898961156961338H010005
2135571783493381H010005
2135571026057080
2135571047779148
2135571063627872
2135571075128803
2135571079093847
2135571104284203

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC162017-07-14
HRS152021-07-27
HSN132020-06-29
KWS112022-03-11
PHX82019-12-02
KWH82003-01-17
KYJ52023-12-14
KYI52011-11-04
KWD52010-01-14
KXE42012-04-09
HSD42007-06-22
JWJ32024-05-30
KWI32004-04-16
HSB22018-11-02
KTT22016-07-06
JDR22013-05-03
LZJ22010-12-21
KWN22008-06-17
NEG22001-11-19

PMN#

GUDID#

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