FDA.reportPublic FDA data

Linvatec Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10172941017294Linvatec Corporation1N2026-01-0111311 Concept Boulevard LARGO FL US 33773

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1728191589189440K993074SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525MAI1999-12-10
1728191831569070K991830CAPSULAR SHRINKAGE ELECTRODEJOS1999-08-20
1728191053270971K991715BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICEMAI1999-08-06
1728191996139925K990524E9000 SYSTEMHRX1999-07-15
1728191020620737K984171ENDOPEARLMAI1999-04-29
1728191892058531K983652ABLATOR ELECTRODEHRX1999-03-23
1728192020148760K983186BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHORMAI1998-10-21
1728191806936418K981764LM ANCHORMBI1998-07-13
1728191745702223K981636INTEGRATED DRIVE/PUMP SYSTEMHRX1998-08-20
1728192069785281K981269UNIVERSAL DRIVE SYSTEMHRX1998-06-24
1728192037374140K973758BIOSCREW ABSORBABLE INTERFERENCE SREWHWC1998-02-27
1728191307365591K971373VISTA SINGLE CHIP VIDEO CAMERAFET1997-05-20
1728191360454347K971059UNIVERSAL DRIVE SYSTEMHRX1997-06-18
1728191106034392K9706053-CCD DIGITAL CAMERAGCJ1997-05-22
1728192050471452K970493HYFRECATOR 2000GEI1997-04-30
1728191833143062K963932PRELOADED SOFT TISSUE ANCHORMBI1997-06-20
1728191750798487K963288LM BONE ANCHORMBI1996-11-13
1728191284626094K963088SHEATH, ELECTROSURGICAL PENCILGEI1996-09-13
1728191905693388K962114ARTHRO-SURGIMATHRX1996-08-22
1728191165291848K962075HSW GMBH ARTHROSCOPEHRX1997-01-17
1728191194728825K961590APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SETHRX1996-10-08
1728191810327689K960962INTERFERENCE SCREWHWC1996-08-19
1728191550376349K960940BIOSCREW ABSORBABLE INTERFERENCE SCREWHWC1996-08-15
1728191447408293K960852HALL MODULAR ACETABULAR REAMER SYSTEMHWE1996-03-20
1728192008488219K960448LM ANCHORMBI1996-04-17
1728191713188434K960439LM BONE ANCHORMBI1996-04-18
1728191948052126K955834SYSTEM 6500 ABC ELECTROSURGICAL UNITGEI1996-07-11
1728191393113336K954682WASHER, BOLT, NUT, ORTHOPEDICHTN1996-02-09
1728191948399358K954440APEX TUBING SETHRX1995-11-02
1728191426791739K953007EXCALIBUR PLUS ELECTROSURGICAL UNITGEI1995-08-21
1728191747491738K951971XENON LIGHT SOURCEGCT1995-05-24
1728191581712585K944992ELECTRODESJOS1995-04-27
1728191906701059K944681LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIESGEI1994-12-22
1728191731331212K943985LIMITED REUSE BLADESHRX1994-11-07
1728191868195736K943949POLYVIOLENE SURGICL SUTUREGAT1994-11-10
1728191639960675K942660HALL MICROCHOICE ELECTRIC POWERED SYSTEMHWE1994-09-07
1728191559075757K941919OKTAS ENDOSCOPY VIDEO CAMERA SYSTEMFET1994-06-17
1728191600139062K941711HYPERFLEX FLEXIBLE GUIDEWIRESLXH1994-08-26
1728191653281876K941541HSV LAPAROSCOPY SETGCJ1994-05-16
1728191671344736K9413883M FLUID IRRIGATION SYSTEMHRX1994-10-07
1728191938749294K933352CONCEPT CANNULATED INTEREFERENCE SCREWHWC1994-02-23
1728191538546276K925098BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDEHTY1994-07-19
1728191979318764K924941CONCEPT 4MM CANCELLOUS SCREW WITH EYELETJDR1993-06-04
1728191182251737K922086BARD BIOPSY FORCEPSGCL1992-10-30
1728191517710886K9120993M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULAHRX1991-12-09
1728191537403668K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
1728192009916132K893732ASPEN DISPOSABLE BIPOLAR CORDGEI1989-07-14
1728191581114511K874676INTERFERENCE SCREWHWC1988-03-07
1728191087480532K864387LUXTEC FIBEROPTIC CABLESEQH1987-05-22
1728191133696357K864385LUXTEC LIGHT SOURCESFCW1987-01-13
1728191432699746K854864BI-POLAR FORCEPSGEI1985-12-24
1728191175537369K852143HALL IRRIGATION SYSTEMGBX1985-06-26
1728191711515376K850749CONCEPT VIDEO IMAGING SYSTEMKQM1985-05-20
1728191051787549K840566BONE STAPLING FIXATION SYSJDR1984-11-23
1728191452799825K833187HALL OSTEONGET1983-10-31
1728191096335930K823424MENISCECTOMY TRAY #9715HAW1983-03-17
1728191541107249K811675SURGICAL INSTRUMENTS FOR USE W/ZIMMERHRX1981-06-25
1728191475196144K801737STERNUM SAWKFK1980-08-20
1728191734452356K800617HYFRECATOR, #733GEI1980-05-02
1728191099600280K800275CEBOTOME DRILLHSZ1980-02-19
1728191577926752K781979SURGAIRTOME TWOHSZ1978-12-20
1728191698343748K771915MICRO OSCILLATING SAWHTZ1977-10-21
1728191533060053K771416IRRIGATION/ASPIRATION NEEDLEHMX1977-09-12
1728191364103917K771007ELECTROSURGICAL POWER GENERATORSGEI1977-09-30
1728191029380440K261363Y-Knotless™ Flex AnchorsMBI2026-05-13
1728191289265074K253763Y-Knotless™ Flex AnchorsMBI2026-01-29
1728191630664704K252946BioBrace® Extra-Articular Ligament Augmentation KitMAI2025-10-15
1728191473350810K251530CONMED Argo Knotless® AnchorMBI2025-06-18
1728191130153379K250395BioBrace ® RC Delivery SystemORQ2025-04-07
1728191077190370K242187BioBrace®OWW2024-11-27
1728191798979236K241906BioBrace® Reinforced ImplantOWW2024-07-29
1728191134088308K240090Argo Knotless GENESYS AnchorMAI2024-03-05
1728191673126344K230547PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil AdapterGEI2023-04-27
1728191345875496K220757Argo Knotless SP AnchorMBI2022-05-13
1728191100097413K220186Zone Specific AIMGAT2022-05-13
1728191828490265K203267The BioBrace ImplantOWW2021-04-30
1728191295290227K201593Looking Glass 4K Integrated Visualization SystemGCJ2020-07-08
1728191536599640K193606Y-Knot OneStep AnchorMBI2020-01-22
1728191556082423K191204Infinity Fixation SystemMBI2019-07-03
1728191762525170K190582MicroLink All-Suture Button Fixation System (Radiopaque)HTN2019-06-28
1728191143059186K190516MicroLink All-Suture Button Fixation System (Radiolucent)HTN2019-06-28
1728191162163426K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2MBI2019-03-18
1728191333905891K182955EZStart Interference ScrewHWC2019-01-22
1728191800298577K182882CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote ControlHRX2018-11-14
1728191266891160K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverMBI2019-01-04
1728191336040020K182446TruShot with Y-Knot All-Suture AnchorMBI2018-12-19
1728191840750499K182439TruShot with Y-Knot Shallow All-Suture AnchorMBI2019-01-08
1728191394656363K180763CuffLink Implant System BiocompositeMAI2018-07-19
1728191795955192K172671HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile PedestalGEI2017-10-04
1728191238041554K172516SurgiQuest AIRSEAL iFS SystemHIF2018-03-16
1728191505373445K171725CuffLink Implant SystemMBI2017-09-08
1728191521787601K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverMAI2017-03-17
1728191185784883K163258CrossFT Knotless Suture Anchor with Disposable DriverMBI2017-01-25
1728191155657421K161017True HD 3MOS Camera SystemGCJ2016-05-09
1728191021868192K152969ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAYKCT2016-03-31
1728191545348551K152860HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTALGEI2015-12-29
1728191775286956K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleMBI2015-07-09
1728191674564269K143404SurgiQuest AirSeal iFS SystemHIF2015-03-20
1728192065005681K142535ConMed Mixing and Delivery KitFMF2015-04-23
1728191704832517K142134C-WIRE DOUBLE ENDED ORTHOPEDIC WIRESHTY2014-09-12
1728191800758025K140101ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARSGCJ2014-07-10
1728191367115920K133224Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURESMBI2014-01-03
1728191642856033K133116VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTICKCT2014-03-28
1728191926504817K132783EXOSHAPE DUO SOFT TISSUE FASTENERMBI2013-12-09
1728191743161077K132169SURGIQUEST AIRSEAL IFSGCJ2013-08-22
1728191730626968K131035Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MMMBI2013-07-02
1728191421871067K130497D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATIONHBC2013-03-29
1728191407242546K121890GENESYS PRESSFT SUTURE ANCHORMAI2012-08-22
1728191547767946K121336MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000HIF2012-07-03
1728191265894754K120841APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHORMBI2012-06-07
1728191922893207K112965NANO SUTURE ANCHORMBI2011-11-02
1728191548947639K111779Y-KNOT ALL-SUTURE ANCHOR MODEL HF13MBI2011-08-08
1728191659432825K111471EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)MBI2011-06-10
1728191815586907K103692SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000HIF2011-05-25
1728191549854284K102410MATRYX INTERFERENCE SCREW (5.0-6.5MM)HWC2010-12-21
1728191968010106K102339CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICEGAT2010-11-23
1728191163965426K1018103DHJD CAMERA SYSTEM MODELGCJ2010-08-30
1728191441372055K101808SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNERHWC2010-11-08
1728191061664249K101100CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503MAI2010-08-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI312026-05-13
HRX212018-11-14
GCJ192020-07-08
HWC182019-01-22
MAI172025-10-15
GEI162023-04-27
GAT42022-05-13
HIF42018-03-16
KCT42016-03-31
HTY42014-09-12
FET42008-06-20
GCT42007-08-20
OWW32024-11-27
HTN32019-06-28
HBC22013-03-29
FCW22008-06-18
FRG22006-10-16
JOS21999-08-20
HWE21996-03-20
JDR21993-06-04
HSZ21980-02-19
ORQ12025-04-07
FMF12015-04-23
GEY12005-05-17
DZI12003-11-10
HAB12001-10-19
LXH11994-08-26
GCL11992-10-30
FST11990-04-23
EQH11987-05-22
GBX11985-06-26
KQM11985-05-20
GET11983-10-31
HAW11983-03-17
KFK11980-08-20
HTZ11977-10-21
HMX11977-09-12