FDA.report

Ascension Orthopedics, Inc.

FDA Registration(s)

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

Registered Device Listings

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
21355710260570801969-12-31
21355710260570801969-12-31
21355710260570801969-12-31
21355710260570801969-12-31
21355710477791481969-12-31
21355710477791481969-12-31

Product Codes Associated With Registrations

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

PMA

PMN

Applications

GUDID

CADENCE®

2020-12-07

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.

CADENCE®

2020-11-30

Ascension Orthopedics, Inc.