FDA.report

DePuy Mitek, Inc.

Matched from indexed company URL: Depuy Mitek

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
12219341221934DePuy Mitek, Inc.1N2026-01-01325 Paramount Dr 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 GUDIDProductPhoneEmail
10886705000951NA - SuperAnchor Threader Tab+1(800)255-2500xx@xx.xx
10886705001088LUPINE ETHIBOND - LUPINE Loop PLUS Anchor w/ETHIBOND PLA Absorbable Anchor, size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm). Size 1 (4 metric) green ETHIBOND eyelet loop.+1(800)255-2500xx@xx.xx

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
17212058891743K993975ABSOLUTE ABSORBABLE INTERFERENCE SCREWHWC1999-12-20
17211538140871K993261TALON ANCHOR SNAP-PAKMBI1999-12-02
17211595909698K992876VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEMHRX1999-09-24
17211105427097K992656DEPUY TOTAL ELBOW SYSTEMJDC1999-11-05
17211805912165K992611MITEK ROTATOR CUFF QUICKANCHOR PLUSHWC1999-09-22
17211502154717K992487MITEK MINI QUICKANCHOR PLUSHWC1999-09-21
17211421479653K992406VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEMGEI1999-08-06
17211636430361K992065GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEADKWS1999-07-12
17211255014652K990454BIO-INTERFERENCE SCREWHWC1999-07-01
17211595115731K984541GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEADKWT1999-01-14
17211790800735K983906DEPUY ORTHOTECH SPIKED WASHERHTN1998-12-18
17211074005197K983818MITEK FASTIN RC ANCHORMBI1998-11-23
17211175202834K983560INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENERMBI1999-01-28
17211719557809K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
17211166599787K981487DEPUY GLOBAL SHOULDER GLENOIDKWS1998-07-13
17211770613169K981340INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEMMAI1998-06-22
17211241253587K980808ENDO FMS UROLOGYLJH1998-05-08
17211227708775K980681INNOVASIVE DEVICES MENISCAL SCREWHWC1998-04-29
17211481687567K974345MITEK KNOTLESS ANCHORMBI1998-02-13
17211793676943K974341MITEK BTB ABSORBABLE (PLA) CROSS PINHTY1998-04-16
17211625391892K974291MITEK BTB ABSORBABLE (PLA) CROSS PINHTY1998-03-05
17211320481348K974022VAPRGEI1998-01-12
17211271670308K973381BIOROC EZ SUTURE BONE FASTENERMAI1998-02-18
17211682570715K972438INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENERMBI1997-09-26
17211775740147K972356INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENERMBI1997-08-26
17211361298641K971996MEDIVISION ARTHROSCOPHRX1997-07-31
17211569669342K971922INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENERMBI1997-08-07
17211658528271K970544DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESISKYJ1997-09-12
17211146572377K970423INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICEMBI1997-04-30
17211739884467K970316INNOVASIVE 8MM LIGAMENT FASTENERMBI1997-04-16
17212031243274K964945INNOVASIVE DEVICES ROTATOR CUFF FASTNERMBI1997-02-24
17211331281836K964013MITEK ABSORBABLE TOGGLE ANCHORMAI1997-02-24
17211055854903K963973DEPUY CANNULATED CROSS PIN SCREW SYSTEMJDW1996-12-16
17211313207837K963783MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USEGEI1996-11-25
17211932542732K961920CROSS PINJDW1996-09-17
17211484769675K961234DEPUY ADVANTAGE FIXATION SCREW SYSTEMHWC1996-06-19
17211077042532K961094MITEK THREADED ANCHOR (MODIFICATION)MBI1996-10-03
17211641204541K954465FMS DUOHRX1995-11-09
17211872124375K952687PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEMMAI1996-02-06
17211222297992K951843REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KITHRX1995-07-14
17211917365284K951702FMS HIGH FLOW ARTHRO-SHEATHHNX1995-05-12
17211747428720K945973FMS ARTHROSCOPY CANNULAHRX1995-03-22
17211520052524K945203MITEK THRADED ANCHOR (MTA)JDR1995-03-06
17211533081237K941541HSV LAPAROSCOPY SETGCJ1994-05-16
17211422837467K935321INNOVASIVE SUTURE BONE FASTENER WITH SUTUREJDR1994-10-19
17211426803482K934366MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHERHWC1994-10-07
17211201634745K930893MITEK SUPER QUICKANCHOR, MODIFICATIONJDR1993-12-08
17211328778596K930892MITEK MINI ANCHOR, MODIFICATIONJDR1994-01-07
17211834636499K924665QUICKANCHORJDR1992-10-27
17211423133585K921873QUICKANCHOR, MODIFICATIONJDR1992-06-09
17211076804411K915889MITEK BONE ANCHOR, MODIFICATIONJDR1992-10-22
17211689184299K915081MITEK SNAP PAK(TM), MODIFICATIONGAS1992-01-31
17211091257445K902751MITEK ANCHOR IIJDR1990-07-24
17211029379975K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
17211590688019K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidKCT2026-02-26
17211771319554K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorMAI2025-02-05
17211345862735K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsMAI2024-09-11
17211417106599K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewMAI2024-03-15
17211842497001K233675FMS VUE™ Fluid Management and Tissue Debridement SystemHRX2024-02-26
17211086971337K2324922.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite AnchorMBI2023-10-06
17211659841201K223211INHANCETM Shoulder System – Humeral Stems and StemlessPHX2022-12-02
17211936911351K221467INHANCETM Reverse Glenoid Peripheral PostsPHX2022-08-31
17211026746105K221364Mitek TIGHT-N AnchorMBI2022-07-11
17211969647497K220219PERMALOOP Suture, PERMATAPE SutureGAT2022-04-26
17211357086982K212933INHANCETM Hybrid Anatomic Glenoid ImplantMBF2022-06-08
17211118020969K212737INHANCE™ Reverse Shoulder SystemPHX2022-04-21
17211493651036K212710GLOBAL UNITE™ Platform Shoulder SystemPHX2021-09-15
17211967085433K212683GLOBAL ICON Stemless Shoulder SystemPKC2022-01-19
17211351808483K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMBI2021-02-01
17211272378112K203694DELTA XTEND Reverse Shoulder SystemPHX2021-07-22
17211399971501K203186DYNATAPE SutureGAT2021-03-18
17211805683005K203108Ignite Stemless Anatomic Shoulder SystemPKC2021-07-16
17211420517452K202716Ignite Anatomic Shoulder SystemMBF2021-05-20
17211848303496K202098GLOBAL UNITE™ Platform Shoulder SystemPHX2020-11-25
17211218435294K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMBI2020-08-07
17211070344318K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMBI2020-06-04
17211932308729K192855DELTA XTEND(TM) Reverse Shoulder SystemPHX2020-02-24
17211897314824K192448Delta Xtend Revers Shoulder SystemPHX2019-10-04
17211683859668K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMBI2019-06-28
17211331499744K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMAI2019-08-22
17211190634712K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMBI2019-07-25
17211200636473K183279HEALIX Ti ANCHOR with DYNACORDMBI2019-02-21
17211018341283K183077Delta Xtend Reverse Shoulder SystemPHX2019-05-17
17211393117166K182941HEALIX ADVANCE SP PEEK AnchorMBI2019-02-26
17211255858662K181809GRYPHON® Anchors with DYNACORD™ SutureMAI2018-08-03
17211049248799K181182DYNACORD SutureGAT2018-08-02
17211842563007K173859HEALIX ADVANCE Anchor with DYNACORD SutureMAI2018-04-11
17211046384713K171237FMS VUE II Fluid Management and Tissue Debridement SystemHRX2018-01-18
17211078838400K171114HEALIX ADVANCE KNOTLESS AnchorMAI2017-11-27
17211968952973K170748GLOBAL UNITE Platform Shoulder SystemPHX2018-01-11
17211098856316K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMAI2017-05-18
17211765621927K162247PERMATAPEGAT2016-12-15
17211232386371K161638SPEEDTRAP Graft Preparation SystemGAT2016-11-07
17211018454069K161001MILAGRO ADVANCE PEEK Interference ScrewMBI2016-06-09
17211408970781K160804INTRAFIX(TM) Advance Tibial Fastener SystemMAI2016-07-19
17211684174146K153667TRUESPAN Meniscal Repair SystemMBI2016-03-24
17211721888066K150209Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop AncMAI2015-10-06
17211321011108K143660Milagro / Milagro Advance Interference ScrewMAI2015-05-21
17211889570836K143475VAPR Tripolar Suction ElectrodeGEI2015-04-03
17211314553745K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,MBI2014-10-24
17211859480052K141259GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEKMAI2014-06-10
17212051015530K140896VAPR ARCTIC SUCTION ELECTRODEGEI2014-08-05
17211697893228K140643GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGYMAI2014-07-08
17211807346443K140324RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XLMBI2014-07-07
17211980383663K133834DEPUY GLOBAL UNITE SHOULDER SYSTEMKWS2014-04-03
17211197865636K1337944.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3MAI2014-02-04
17211791458325K132241GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT TMAI2013-11-05
17211500870186K131974HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)MAI2013-07-25
17212009914647K131683HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)MBI2013-06-27
17211945902099K1311914MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUSHRX2013-07-22
17211832806969K130917HEALIX ADVANCE KNOTLESS BR ANCHORMAI2013-05-24
17211570272602K130912OMNICUT RESECTION BLADEHRX2013-06-14
17211606118293K130814RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMMBI2013-08-01
17211101576846K130539HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)MBI2013-05-21
17211258963279K130169FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLEHRX2013-05-01
17211113897950K130105RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEMHTY2013-05-17
17211279699118K123668ORTHOCORDNEW2013-02-26
17212059096089K123362MILAGRO ADVANCE INTERFERENCE SCREWHWC2013-02-01
17211455737251K123359OVS1 VIDEO SYSTEMFCW2012-12-19
17211034601622K122869MILAGRO INTERFERENCE SCREWSMAI2012-12-13

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MAI362025-02-05
MBI322023-10-06
HWC322013-02-01
PHX192022-12-02
JDR182007-06-29
HRX152024-02-26
GEI122015-04-03
KWS92014-04-03
MBF52022-06-08
GAT52022-04-26
HTY52013-05-17
NEW42013-02-26
HSN32012-10-31
KYJ32009-02-09
HSD32008-12-18
PKC22022-01-19
JDC22006-04-14
JDW21996-12-16
KCT12026-02-26
FCW12012-12-19
GAM12005-04-08
NOV12003-08-25
KWT11999-01-14
HTN11998-12-18
EOB11998-08-13
LJH11998-05-08
HNX11995-05-12
GCJ11994-05-16
GAS11992-01-31
FST11990-04-23

PMN

ORTHOCORD

2013-02-26

DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY

VARIOUS

2012-01-13

DEPUY MITEK, A JOHNSON & JOHNSON COMPANY

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GUDID

80 records. Showing 1-40. Next