FDA.report

MEDACTA INTERNATIONAL SA

Matched from indexed company URL: Medacta International SA

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30081105333008110533MEDACTA INTERNATIONAL SA1N2026-01-01Via Alla Rossa 6 Rancate Ticino CH 6862

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1916901793527062K964402VERSATRAC (TM) LUMBAR RETRACTOR SYSTEMGZT1997-01-23
1916901712692956K792558CONTAINER SYSTEMFLE1979-12-27
1916901840136140K254202MectaLIF 3D Metal AnteriorOVD2026-05-05
1916901506951870K253940M.U.S.T. Pedicle Screw System - ExtensionNKB2026-04-28
1916901741856408K253328GMK 3D Metal Tibial Tray ExtensionMBH2026-02-26
1916901666747391K252847NextAR Hip PlatformSBF2026-01-09
1916901793311281K252225PowerKnot High Strength SuturesGAT2025-09-12
1916901515472498K251933SnugFit ASA ExtensionMBI2025-07-01
1916901194423170K251737NextAR(TM) Shoulder PlatformSBF2025-09-04
1916901850359741K251618MOTO Partial Knee System ExtensionHSX2025-07-24
1916902012348631K251166Mfinity Femoral SystemMEH2025-06-13
1916901363324227K251043Mpact 3D Metal Implants Extension – DMLS TechnologyLPH2026-01-28
1916901114681460K251016MectaLIF 3D MetalMAX2025-07-17
1916901143132866K250644MSS - Monobloc stemPHX2026-02-03
1916901330051494K250477NextAR(TM) SpineSBF2025-07-31
1916901560483065K250450Coated hip implantsLZO2025-09-19
1916901984373453K250338MSS - Humeral reverse liners extensionPHX2025-10-31
1916901142561737K243697MySpine WebPlannerLLZ2025-04-23
1916901014241615K242603MyPAO SA guidesPBF2025-11-19
1916901556226418K242232Mpact 3D Metal Augments IILPH2025-04-23
1916902059652684K241767Versacem Acetabular Shell and Double Mobility HC LinersLZO2025-03-06
1916901233312966K241461Mpact Constrained LinerKWZ2025-07-31
1916901591546218K241292MyShoulder Planner (5.3SSWPL)KWS2025-01-30
1916901561120376K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemPML2024-06-12
1916901535956576K234048M.U.S.T. Pedicle Screw System - ExtensionNKB2024-02-13
1916901820643043K233172NextAR™ Spine PlatformSBF2024-04-24
1916901858514797K232733Mbrace CableJDQ2024-05-03
1916901816346930K232513X-Twist Biocomposite Suture AnchorMAI2023-09-18
1916901676802230K232280NextAR™ TSA PlatformSBF2023-10-29
1916901810011714K232123MectaLIF Anterior Lag ExtensionOVD2023-10-18
1916901184518815K231911Glenoid Reconstruction System – Full Wedge BaseplatePHX2023-11-09
1916901619903565K231515MySpine Cervical GuidesQSD2023-12-07
1916901967788922K231483MySpine Unilateral GuidesPQC2023-07-21
1916901686793769K231037MyKnee UNI-STJWH2023-06-09
1916901692988058K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantMBI2023-12-28
1916901976485643K230544SnugFit All-Suture Anchor extensionMBI2023-04-17
1916901294897064K230394EUROSCREW NG; EUROSCREW TCP NGMAI2023-05-12
1916901802496929K230011Mpact ExtensionLPH2023-09-20
1916902054510783K223795FairFix QT Adjustable ButtonMBI2023-01-17
1916901745330689K223769NextAR™ Spine PlatformSBF2023-07-21
1916901035742154K223582MectaLock TI Triple Loaded Suture AnchorMBI2023-02-24
1916901790377907K223548GMK Sphere & GMK SpheriKA CementlessMBH2023-01-20
1916901108271619K222169FairFix Adjustable Button SystemMBI2022-08-16
1916901046097886K221850GMK 3D Metal Tibial TrayMBH2022-08-23
1916901982153315K221725Advanced MyHip PlannerLLZ2023-01-20
1916901703639869K221545MectaLIF Anterior ExtensionOVD2022-10-24
1916901640959506K221502Parcus Synd-EZ SSMBI2022-07-26
1916901112715039K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMBI2022-06-08
1916901297225332K221135X-Twist PEEK Suture AnchorMBI2022-05-19
1916902005688164K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesQSR2022-05-24
1916901059604261K220706MyPAO GuidesPBF2023-05-30
1916901496805995K220705MyKnee R Pin PositionersJWH2022-05-04
1916901062448587K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionNKG2022-04-26
1916901409869415K220405Amis K LongLZO2022-04-12
1916902005861314K213751NextAR™ TKA Platform My Knee PPSSBF2022-03-10
1916901904836041K213459Glenoid Reconstruction SystemPHX2022-11-23
1916901346794744K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionHSX2021-11-16
1916901446942908K212831MectaLIF ExtensionMAX2021-10-29
1916901190736494K212739ActiFlipMBI2021-10-06
1916901151770760K212327M-Vizion MonoblocLZO2022-05-24
1916901401514551K211891DM Converter - TiN coatedLZO2022-07-22
1916901593555485K211664GMK Sphere RevisionJWH2021-07-29
1916901577180324K211435PAO Cortical ScrewHWC2021-08-06
1916901304263136K211386MySpine WebPlanner & MyBalanceLLZ2021-07-23
1916901974828697K211004GMK Spherika Femurs and Fixed Tibial Trays PlusJWH2021-05-13
1916901106666270K210859NextAR™ Spine PlatformSBF2021-11-05
1916901206866861K210456Ligament StapleJDR2021-04-12
1916901697928203K210427M.U.S.T. Midline Cortical (MC) Screw SystemNKB2021-04-20
1916901751840677K210263Mpres Neck Preserving StemLZO2021-09-22
1916901261010211K210207Humeral Eccentric Reverse MetaphysisPHX2021-03-26
1916901502515875K210153NextAR RSA PlatformSBF2021-05-12
1916901313012223K210062Mectaplug PE IIJDK2021-04-08
1916901235495464K210010GMK Revision & Hinge Extension - TiNbN CoatingKRO2021-03-02
1916901860387921K203755Shoulder System - TiNbN CoatingPHX2021-03-02
1916901288235280K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)PQC2021-04-06
1916901332346861K203671M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemOUR2021-01-13
1916901765224939K203493MectaLock ExtensionMAI2021-02-22
1916901411692725K203485SnugFit All-Suture AnchorMBI2021-01-19
1916901562508933K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsNKB2021-01-26
1916901389888302K203335MectaScrew ExtensionHWC2022-02-03
1916901482230026K203259FairFix Adjustable Button SystemMBI2021-03-26
1916901972607040K203149M.U.S.T. MINI Posterior Cervical Screws SystemNKG2020-11-16
1916901260769114K203076Mecta-C Stand Alone ExtensionOVE2020-11-06
1916901574959620K203041SMS Cementless StemLZO2020-12-02
1916901865434458K202730Quadra-PLZO2020-12-28
1916901136389900K202684GMK Total Knee System - TiNbN CoatingJWH2020-12-11
1916901865599663K202662Parcus Titanium Interference ScrewsMBI2021-02-22
1916901755073674K202568Mpact® 3D Metal Implants - DMLS TechnologyLPH2021-12-20
1916901347467574K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate HipMBI2020-10-28
1916901863782621K202152NextAR TKA PlatformSBF2020-10-27
1916901245876080K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)JWH2020-09-18
1916901811586139K201673SMS Cementless StemLZO2020-09-18
1916901488911238K201471M-Vizion Femoral Revision System ExtensionLZO2021-01-11
1916902027646341K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsMBI2020-07-23
1916901345893649K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesPQC2020-10-05
1916901726340856K200589MyPAO Planning ReportLLZ2021-02-19
1916901555646826K200551MectaLIF Transforaminal TiPEEKMAX2021-02-12
1916901553393132K200391MPACT ExtensionLPH2021-04-28
1916901647586737K200350MyHip Planner & VerifierLLZ2020-11-04
1916901289684147K200130M.U.S.T. MINI Posterior Cervical Screws SystemNKG2020-02-10
1916901444231930K200122MOTO PFJ SystemKRR2020-04-20
1916901147397274K2000753DMetal Diaphyseal Femoral ConesJWH2020-03-13
1916901000063625K200067MectaScope SystemHRX2020-10-01
1916901763645380K200048MectaLIF Anterior SimpleMAX2020-03-09
1916901600267707K193559NextAR TKA PlatformSBF2020-07-10
1916901151939843K193461MectaLock All-Suture AnchorsMBI2020-02-06
1916901581773275K193433AMIStem-CLZO2020-01-09
1916901912737413K193365M.U.S.T. Pedicle Screw SystemNKB2020-01-27
1916901662434470K193295Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorMBI2020-01-23
1916901013701216K193175Lateralized GlenospherePHX2020-08-11
1916901062704966K193165MectaFix CL Fixation Button with Continuous LoopMBI2020-02-10
1916901692368507K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemOUR2019-12-03
1916901338003243K192967Medacta Shoulder SystemPHX2020-03-25
1916901007157098K192964Parcus Synd-EZ SSMBI2019-11-22
1916901049522558K192906Mecta-C Stand AloneOVE2020-03-04
1916901958133650K192827Quadra-PLZO2020-01-06
1916901340544261K192824Parcus Knotless AP Suture AnchorsMAI2019-11-02
1916901043094227K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipMBI2020-01-16
1916902019502957K192352MiniMAXLZO2019-09-27
1916901813444268K192126AMIStem-P Short NeckLZO2019-11-22

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MBI422025-07-01
LZO372025-09-19
JWH272023-06-09
PHX132026-02-03
NKB122026-04-28
SBF112026-01-09
LPH102026-01-28
MAX92025-07-17
HWC92022-02-03
OVD72026-05-05
NKG62022-04-26
HSX52025-07-24
LLZ52025-04-23
MAI52023-09-18
PQC42023-07-21
KRO42021-03-02
MBH32026-02-26
GAT32025-09-12
MEH32025-06-13
OUR32021-01-13
ODP32017-09-18
JDI32008-12-29
MQV32004-12-27
PBF22025-11-19
KWS22025-01-30
JDK22021-04-08
OVE22020-11-06
MNI22016-06-29
LOD22009-11-24
FRG22006-02-15
KWZ12025-07-31
PML12024-06-12
JDQ12024-05-03
QSD12023-12-07
QSR12022-05-24
JDR12021-04-12
HRX12020-10-01
KRR12020-04-20
KWQ12014-06-12
KWP12012-07-18

PMA

PMN

Applications

GUDID