FDA.report

Garry Hayeck

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
80310203002807830Garry Hayeck1N2026-01-01325 Corporate Drive -- Mahwah NJ US 07430

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
37661229156890P960053BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESISKWG1997-06-19
37661081715721K992063OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOYHSB1999-09-03
37661877557527K983508OSTEO COMPRESSION CONDYLE SCREW SYSTEMHWC1998-12-07
37662053446659K983419HOFFMANN II MIAMI POSTHRS1998-11-25
37661751016978K983339OSTEO DYNATROC PROXIMAL FEMORAL NAILHSB1998-10-27
37661065016913K983165OSTEO 4.0MM CANNULATED SCREW SYSTEMHWC1998-12-03
37661761663732K983006OSTEO 5.0MM CANNULATED SCREW SYSTEMHWC1998-11-23
37661252467135K982553OSTEO COMPRESSION HIP SCREW SYSTEMHRS1998-09-22
37662029806659K982288RADIAL HEAD IMPLANTKWI1998-09-08
37661340286777K982268ULNAR HEAD IMPLANTKXE1998-12-04
37661488323237K982068HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEMJDW1998-08-31
37661709661423K981283ROGACHEFSKY DISTAL RADIUS PLATESHRS1998-06-10
37661013791300K981259OSTEO 4.0MM CANNULATED SCREW SYSTEMHWC1998-05-11
37661479061609K980364HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERSHWC1998-04-29
37661639045968K974289EPI-UNION PLATING SYSTEMHRS1998-02-12
37661657809398K973438OSTEO BOS SYSTEM PRODUCT LINE EXTENSIONHRS1997-12-09
37661847723504K973321HOFFMANN II COMPACT PERIARTICULAR CLAMPKTT1997-11-20
37661812225596K973204OSTEO BOS SYSTEM IN STAINLESS STEELHRS1997-09-25
37661825308313K972323OSTEO BOS SYSTEMHRS1997-09-10
37661940539743K972196OSTEO ANATOMICAL BONE PLATESHRS1997-08-25
37661912664637K971962OSTEO KIRSCHNER WIRESHTY1997-08-11
37662059385358K971800OSTEO CANNULATED SCREW SYSTEMHWC1997-07-30
37661684835779K971778OSTEO SMALL AND MINI BONE SCREWSHWC1997-06-27
37661310198988K971755HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEMJEC1997-07-17
37661709338236K971654OSTEO COMPRESSION HIP SCREW SYSTEMHWC1997-07-09
37661529859855K971321OSTEO COMPRESSION CONDYLE SCREW SYSTEMHRS1997-07-09
37661348824390K964893HANSSON PIN SYSTEMJDW1997-02-28
37661639742131K963940EXETER MESHJDJ1997-02-13
37661110449742K963614MONOTUBE CARBON TUBEJEC1996-11-06
37661768056780K961916HOFFMANN II CARBON CONNECTING RODJEC1996-08-01
37661514002971K961618MONOTUBE TUBE TO RING CLAMPJEC1996-05-28
37661574641697K961497PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEMHRS1996-06-28
37661582378370K961496R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEMHRS1996-06-28
37661837393226K961213ALTA DOME AND PLUNGER (MEC HIP BOLT)KTT1996-06-13
37661617102949K955306OMEGA+ COMPRESSION SCREW SYSTEMKTT1996-04-10
37661328674290K954667MONOTUBE TUBE-TO-TUBE CLAMPJEC1996-01-11
37661782969162K954554ALTA TIBIAL/HUMERAL RODHSB1995-12-13
37661397967617K952730HOFFMANN II EXTERNAL FIXATION SYSTEMJEC1995-09-08
37661317790079K945233PEDIATRIC OSTEOTOMY SYSTEMKTT1995-02-01
37661267160883K940230ENDOSCOPIC MORTONS NEUROMA INSTRUMENTSHRX1994-12-12
37661995051678K936124HOWMEDICA MONOTUBE T-CONNECTORJEC1994-02-22
37661010603835K934698HOWMEDICA MONO-TUBE SINGLE PIN CLAMPJEC1994-02-22
37661202595012K931588SUTTER PROXIMAL INTERPHALANGEAL JOINTKYJ1994-03-10
37661122068143K930836HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEMKTT1995-01-18
37661150395557K925127ALTA CANCELLOUS BONE SCREWKTT1993-03-22
37661283418749K922391ENDOSCOPIC CARPAL TUNNEL INSTRUMENTSHRX1992-08-18
37661274709756K922295OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATIONKTT1992-09-08
37661062743373K914374OSTEO CERCLAGE WIREJDQ1991-12-30
37661368152551K911398ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEMHWC1991-06-27
37661704591096K910993MORREY ELBOW FIXATORKTT1992-11-25
37661969471419K910986HOFFMANN DYNAMIC WRIST FIXATORKTT1992-01-16
37661368429883K910483MONOTUBE EXTERNAL FIXATION SYSTEMKTT1992-07-14
37662022568746K910482ALTA CHANNEL PLATE CONNECTORHRS1991-07-30
37661983268966K900584ALTA LAG SCREW AND COMPRESSION SCREWKTT1990-04-18
37661786273767K885250ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYSHRS1989-02-13
37661945065649K883882HUMERAL LOCKING NAIL SYSTEMJDS1989-01-30
37661388611706K870200SUTTER FINGER JOINT PROSTHESISKYJ1987-10-09
37661429366968K864403MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEMLXT1986-12-18
37661761003784K861766HOWMEDICA HOFFMANN FIXATION PIN SYSTEMJDW1986-07-08
37661141574767K822943ELLISON VITALLIUM FIXATION STAPLE SYSJDR1982-10-27
37661067363026K821252HOFFMAN UNIVERSAL FOOT SUPPORTKQZ1982-06-22
37661402125981K803166DOUBLE BALL JOINTJEC1981-01-09
37661762785060K801969ASNIS GUIDED SCREW SYSTEMSHNC1980-08-27
37661648500540K800806I.C.S. MINI & SMALL FRAGMENT SETHRS1980-04-21
37661469506578K792561MINI-H-FIXATIONJEC1979-12-19
37662022927170K790501PEDIATRIC OSTEOTOMY SYSTEMKTT1979-04-10
37661610902078K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemHSB2026-02-03
37661341592384K253202Hoffmann LRF SystemKTT2025-12-19
37662039697388K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemHSB2025-08-20
37661068206268K250163T2 Alpha Femur Retrograde Nailing SystemHSB2025-08-13
37661854797367K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating SystemHRS2024-10-06
37661760953748K233919VariAx 2 Distal Radius SystemHRS2024-03-25
37661739720439K233741Hoffmann LRF SystemKTT2023-12-21
37661444081616K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating SystemHRS2023-08-18
37661046433112K231257Pangea Utility Plating System, Pangea PlatformHRS2023-08-18
37661636630163K230512Gamma4 SystemHSB2023-06-09
37661905956110K223772PRO Plating System, Stryker Trauma Pelvic Set (Matta)HRS2023-04-07
37661549140598K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemHRS2023-04-27
37661338150198K222309Gamma4 SystemHSB2022-11-15
37661098562917K221346Stryker VariAx 2 MIS CalcaneusHRS2022-07-08
37661955653905K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemHWC2022-06-10
37661441872674K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemHSB2022-02-11
37661996534351K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemHWC2022-01-11
37661852581589K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemHRS2022-01-19
37661071161219K211508Steinmann Pins and Kirschner WiresJDW2021-10-05
37661304789983K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)KWS2021-09-03
37661729464704K210582EasyClip® and EasyClip® XpressJDR2022-06-10
37661199319893K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail SystemHSB2021-02-26
37661755333410K202749ADAPT for Gamma3OLO2020-12-18
37661307708830K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)KWS2020-12-16
37661215855629K200869Gamma3 SystemHSB2020-07-22
37661369164479K200398AxSOS 3 AF System and AxSOS 3 Ti SystemHRS2020-06-05
37661315188392K193366T2 ICFHWC2020-03-20
37661067708253K193308T2 Alpha Tibia Nailing System, IMN Screws SystemHSB2020-02-23
37661494787683K192675VariAx FootHRS2019-11-22
37661820571142K191412VariAx 2 System, VariAx 2 Mini Fragment SystemHRS2019-08-23
37661778157237K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments SystemHSB2019-06-11
37661765920844K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)KWS2019-02-15
37661891039727K181848ADAPT for Gamma3, Gamma3OLO2018-10-12
37661009870772K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)KWS2018-09-27
37661109360697K181091AxSOS 3 TiHRS2018-10-11
37661682405558K180500VariAx 2 SystemHWC2018-06-04
37661740727110K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemHSB2018-06-06
37661716176514K173946ADAPT for Gamma3OLO2018-05-02
37661849516041K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemHSB2018-01-12
37661059549551K172350AxSOS 3 TiHRS2017-12-15
37661411083879K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)KWS2017-10-02
37661857012913K170771VariAx 2 Foot SystemHRS2017-05-08
37661073280801K170727VariAx 2 Compression Plating SystemHRS2017-06-22
37661978241081K170418Stryker SonicPin SystemHTY2017-06-20
37661286019462K163656Hoffmann LRF SystemKTT2017-04-14
37661314323841K162841VariAx Distal Radius Plating System, VariAx 2 SystemHRS2017-02-21
37661920722893K162439AxSOS 3 Ti; Stryker Plating SystemHRS2017-02-03
37661784888109K162321EasyClip XpressJDR2017-02-10
37661082907362K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)KWS2016-11-23
37661657707895K161778ToeTac™ 10° Hammertoe Fixation SystemHWC2016-11-22
37661811039906K160813EasyStepJDR2016-07-26
37661766510639K153379AxSOS 3TiHRS2016-05-26
37661275836614K153377Hoffmann LRF (Limb Reconstruction Frame) SystemKTT2016-04-11

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HRS822024-10-06
HSB452026-02-03
KTT432025-12-19
HWC312022-06-10
JEC132011-01-14
LXT102005-06-17
HTY92017-06-20
JDR82022-06-10
JDW82021-10-05
KWS72021-09-03
OLO42020-12-18
KWI42006-11-13
JDB32010-12-20
KXE32006-07-19
KYJ32002-01-25
HRX21994-12-12
PHX12013-12-27
HTN12011-08-31
FTD12010-06-25
HBE12007-04-27
JEY12002-12-17
JWJ12002-12-02
HAW12001-08-31
KTW12000-08-04
KWG 11997-06-19
JDJ11997-02-13
JDQ11991-12-30
JDS11989-01-30
KQZ11982-06-22
HNC11980-08-27