FDA.reportPublic FDA data

DEPUY SPINE, INC.

Matched from indexed company URL: Depuy Spine

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15264391526439DEPUY SPINE, INC.1N2026-01-01325 Paramount Drive RAYNHAM MA US 02767

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
10705034471716N/A - MODIFIED INSTRUMENT ROD HOLDER WITH STOPS+1(800)255-2500xx@xx.xx
10705034570105N\A - MODIFIED INSTRUMENT PADDLES+1(800)255-2500xx@xx.xx
10705034570211N/A - MODIFIED INSTRUMENT DRIVER X25+1(800)255-2500xx@xx.xx
10705034570228N\A - MODIFIED INSTRUMENT KNOB+1(800)255-2500xx@xx.xx
10705034570433N/A - MODIFIED INSTRUMENT REDUCER CLIP+1(800)255-2500xx@xx.xx
10705034570501N\A - MODIFIED INSTRUMENT INSERTER+1(800)255-2500xx@xx.xx
10705034570624N/A - MODIFIED INSTRUMENT REDUCER JOYSTICK+1(800)255-2500xx@xx.xx
10705034570693N\A - MODIFIED INSTRUMENT CLAMP+1(800)255-2500xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
28881955423741P960025BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWSMAX1999-02-02
28881949393783K993099BREMER HALO SYSTEM TITANIUM SKULL PINJEC1999-12-15
28881292747986K993030MODIFICATION TO ISOLA SPINAL SYSTEMKWQ1999-12-29
28881938369513K992898THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEMGZT1999-10-21
28881927736523K992168MOSS MIAMI 6.35MM POLYAXIAL SCREWKWQ1999-09-23
28881289296469K990148STACKABLE CAGE SYSTEMMQP1999-09-03
28881945274557K984378DEPUY ACROMED MOSS SPINAL SYSTEMMNI1998-12-30
28881698049520K984350VSP SYSTEMMNI1999-01-20
28881207792299K984348TIMX LOW BACK SYSTEMMNI1999-01-20
28881983464447K983583DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMSKWP1998-12-03
28881823803013K982443DOC VENTRAL CERVICAL STABILIZATION SYSTEMKWQ1998-07-29
28881632974416K982320DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMKWP1998-09-14
28881281038153K982011DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMKWP1998-08-06
28881347283033K981714TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEMMNH1998-06-30
28881306387633K981274ACROMED TIMX PLATE BASED LOW BACK SYSTEMMNH1998-04-29
28881493816795K981113PEDIATRIC PRCMNH1998-05-29
28881871559812K980485ISOLA SPINAL SYSTEMMNI1998-10-21
28881454863821K980447DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMMNH1998-04-14
28881425421450K980228UNIVERSITY PLATE ANTERIOR SYSTEMKWQ1998-04-14
28881380954098K974757KANEDA ANTERIOR SCOLIOSIS SYSTEM KASSKWQ1998-03-05
28881756818765K974573DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEMKWP1998-02-18
28881217316727K974245DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRILXT1998-05-22
28881023357415K973060DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEMKWQ1997-11-03
28881921918848K972718M-2 ANTERIOR PLATE SYSTEMKWQ1997-10-01
28881106121613K972568DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEMMNH1997-09-19
28881880306014K971730DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEMKWQ1997-11-03
28881047888419K971248KANEDA SR ANTERIOR SPINAL SYSTEMKWQ1997-06-11
28881269124168K970955ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEMKWQ1997-06-11
28882071856882K970950EASY RODMNH1997-06-03
28881491804805K970462ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEMKWQ1997-04-03
28881106129420K965145DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMKWP1997-03-13
28881095686778K965102ACROMED PEDICLE SCREWMNH1997-05-08
28881849002252K965046ISOLA TWISTER CONNECTORMNH1997-03-14
28881306458467K964024DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEMKWP1997-03-26
28881131628669K964007ACROMED CABLE/WIRE PEDICLE SCREWMNH1996-12-16
28881283184866K963639ACROMED PEDICLE SCREWKWP1996-11-14
28881084893089K963350DEPUY MOTECH PEAK FIXATION SYSTEMHWC1996-11-14
28881137829487K962984ISOLA PEDIATRIC COMPONENTSKWP1996-11-27
28881809820705K962645ISOLA TWISTER CONNECTORMNH1996-10-22
28881823371346K962628MOSS MIAMI SPINAL SYSTEMKWP1997-03-18
28881222445049K962486DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEMKWQ1996-12-27
28881040942659K955348TITANIUM MOSS MIAMI SPINAL SYSTEMKWP1996-02-16
28881591090575K954069ACE CERVICAL TRACTION HALOZS, TONGS & PINSHAX1995-10-12
28881458562372K953978ANTERIOR DYNAMIZED SYSTEMKWQ1997-02-19
28881917804919K953915MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)MNH1996-02-15
28881847367782K952236ISOLA SYSTEMMNH1996-01-22
28881976531501K951657VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S)MNH1995-08-21
28881898889870K951116ACROMED PEDICLE SCREWMNH1995-08-11
28881664555290K950697DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATIONMNH1995-06-22
28881116012526K950695DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATIONMNH1995-07-21
28881567591243K944756ISOLA OPEN AND CLOSED SCREWSMNH1995-05-30
28881919360062K944737ISOLA SPINE SYSTEMMNH1995-06-22
28881947481401K944736VSP (VARIABLE SCREW PLACEMENT)MNH1995-05-05
28881196243612K943819ISOLA ANTERIOR SYSTEMKWQ1995-02-09
28881788011547K933881DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEMKWP1994-07-12
28881144730076K926116CODMAN SOFWIRE(TM) KITJDQ1993-03-30
28881369310248K923869CODMAN SOF'WIRE TITANIUM CABLE SYSTEMJDQ1993-05-12
28881119688272K923703KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEVKWQ1993-05-20
28881710359411K922952SONGER CABLE SYSTEMJDQ1993-02-23
28881644748810K922504ISOLA(R) TANDEM CONNECTORKWP1993-05-18
28881350626035K921090ISOLA(R) TRANSVERSE ROD DUAL CONNECTORKWP1992-12-31
28881841962727K920392ISOLA SPINE SYSTEM: PLATE-ROD COMBINATIONKWP1992-12-31
28881454852926K915800BREMER HALO SYSTEM CERVICAL TRACTION SKULL PINJEC1992-03-16
28881729418075K911528ISOLA(TM) SPINE SYSTEM - ILIAC SCREWKWP1991-06-28
28881696411737K911394ISOLA(TM) SPINE SYSTEM--EYE RODKWP1991-06-21
28881115908592K905826ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTORKWP1991-03-21
28881563471650K905184ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOKKWP1991-02-15
28881306686314K903810ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREWHWC1990-10-16
28881632836094K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
28881929671214K900138MOTECH TITANIUM SURGICAL MESHEZX1990-03-20
28881003989471K895441ACROMED BUTTON SPINAL WIREKWP1989-11-22
28881728060410K895439ACROMED BEADED SUBLAMINAR WIREKWP1989-11-22
28882043283928K895413ACROMED DOUBLE SUBLAMINAR WIREKWP1989-11-22
28881703086331K894184BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEMJDN1990-04-25
28881608728029K884163ACROMED SPINAL ROD AND SPINAL HOOKSKWP1989-04-26
28881764465704K881699ACROMED WASHERSHTN1988-04-27
28881641908780K875053ACROMED CANCELLOUS BONE SCREWHWC1988-01-20
28882020481682K873826ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATIONKWQ1988-11-30
28881363083408K862552ACROMED ADS BONE NAILKTW1986-09-02
28881822897884K842680ACE UNIVERSAL TONGHAX1984-09-04
28881803600667K810193TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONGHAX1981-03-20
28881887903328K792586HALO SUPPORT JACKET & ASSOC. HARDWAREHAX1979-12-31
28881429677497K760649TOTAL SPINAL CORRECTIONJDN1976-10-05
28881375623859K260240SYMPHONY Navigation Ready InstrumentsOLO2026-03-27
28881112563822K253249TriALTIS™ Spine SystemNKB2025-10-21
28881104833993K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteMQV2025-10-22
28881449321637K251648GPS Advanced; GPS Advanced CannulaFMF2025-06-24
28881534451544K243249TriALTIS™ Spine SystemNKB2025-01-17
28881820599464K242042TriALTIS™ Spine SystemNKB2024-09-09
28881941961287K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysOLO2024-09-16
28881637604488K241426GPS Advanced; 5 cc GPS Advanced CannulaFMF2024-07-10
28881462596913K233684TriALTIS™ Spine SystemNKB2023-12-12
28881451216378K233366SYMPHONY OCT SystemNKG2023-11-09
28881541251684K233256Robotic Integration InstrumentsOLO2024-06-17
28881085580434K233255CROSSNAV Navigation Enabled InstrumentsOLO2024-06-17
28881773316673K233254TELIGEN System Navigation Ready InstrumentsOLO2024-06-14
28881536701205K233228Spine Navigation and Robotic-Assistance DeviceOLO2024-06-14
28881186655556K231527TriALTIS Navigation Enabled InstrumentsOLO2023-09-29
28881002079679K231479TriALTIS Spine SystemNKB2023-09-22
28881283132178K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMAX2023-03-08
28881904567002K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsPDQ2023-02-10
28881993275308K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)OLO2023-01-19
28881611536717K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsNKB2022-10-13
28881886053463K222276CONDUIT Cages; FIBERGRAFT BG PuttyODP2022-10-15
28881154358701K221325CONDUIT Lateral Switch PlateMAX2022-08-25
28881257544347K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)NKB2022-03-08
28881872174300K213978TELIGEN SystemHRX2022-10-18
28881762423484K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteMQV2022-08-23
28881250875620K210728CONDUIT InstrumentsMAX2021-05-06
28881351045064K203319SYMPHONY™ OCT SystemNKG2021-02-05
28881294458123K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF CageMAX2020-07-15
28881875377960K192646SYMPHONY™ OCT SystemNKG2020-04-02
28881155180746K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine SystemPGM2019-09-24
28881337906728K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation SystemNKG2019-07-18
28881972295328K183447EIT Cellular Titanium Lumbar Cage - T/PLIFMAX2019-02-04
28881123573997K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteMQV2018-12-20
28881760944736K181949SYMPHONY™ OCT SystemNKG2018-10-04
28881220018026K181644EIT Cellular Titanium® Lumbar Cage LLIFMAX2018-10-12
28881808555260K180080FIBERGRAFT BG Matrix Bone Graft SubstituteMQV2018-04-06
28881603693267K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with FenestrationsNKB2017-10-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB412025-10-21
KWP372014-10-01
MNH342006-11-02
KWQ302013-09-06
MAX182023-03-08
MQP132008-05-01
MQV122025-10-22
MNI112004-06-02
OLO102026-03-27
NKG62023-11-09
GZT42012-01-27
LYC42010-05-25
NDN42007-11-21
HAX41995-10-12
FMF32025-06-24
HWC31996-11-14
JDQ31993-05-12
PGM22019-09-24
MRW22010-11-15
JEC21999-12-15
JDN21990-04-25
PDQ12023-02-10
HRX12022-10-18
ODP12022-10-15
PML12016-12-20
OSH12013-09-12
NQW12010-01-07
OUR12005-08-26
GEY12001-11-14
LXT11998-05-22
FST11990-04-23
EZX11990-03-20
HTN11988-04-27
KTW11986-09-02

PMA#

PMN#

75 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next