FDA.reportPublic FDA data

Medacta USA, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066399163006639916Medacta USA, Inc.1Y2026-01-016386 Global Drive, Suite 101 Memphis TN US 38141

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
837331289684147K200130M.U.S.T. MINI Posterior Cervical Screws SystemNKG2020-02-10
837331147397274K2000753DMetal Diaphyseal Femoral ConesJWH2020-03-13
837331763645380K200048MectaLIF Anterior SimpleMAX2020-03-09
837331151939843K193461MectaLock All-Suture AnchorsMBI2020-02-06
837331581773275K193433AMIStem-CLZO2020-01-09
837331912737413K193365M.U.S.T. Pedicle Screw SystemNKB2020-01-27
837331062704966K193165MectaFix CL Fixation Button with Continuous LoopMBI2020-02-10
837331692368507K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemOUR2019-12-03
837331338003243K192967Medacta Shoulder SystemPHX2020-03-25
837331049522558K192906Mecta-C Stand AloneOVE2020-03-04
837331958133650K192827Quadra-PLZO2020-01-06
837332019502957K192352MiniMAXLZO2019-09-27
837331813444268K192126AMIStem-P Short NeckLZO2019-11-22
837331744799177K191677MectaTap TI Suture AnchorMBI2020-01-29
837331992742161K191300MectaLock Ti Suture AnchorMBI2019-09-12
837331053209018K191145MasterLoc ExtensionLZO2019-05-30
837331847445140K190892MectaScrew PEEK Interference ScrewMBI2019-06-04
837331899136145K190738MyShoulder Placement GuidesPHX2019-12-13
837331045281980K190631M.U.S.T. MINI Posterior Cervical Screws SystemNKG2019-04-10
837331437870632K190474MectaLock PEEK Suture AnchorMBI2019-05-28
837331140929015K183582MPACT ExtensionLPH2019-03-21
837331582595664K183426MectaLIF Anterior Stand Alone ExtensionOVD2019-03-15
837331027765523K183029MOTO Partial Knee SystemHSX2019-01-30
837331882472926K182837M.U.S.T. Mini ExtensionNKG2019-01-22
837331111246403K181970MectaLIF Posterior ExtensionMAX2018-12-04
837331761179680K181826Glenoid Polyaxial Non-locking ScrewsPHX2018-12-10
837331336469093K181693SMS Femoral StemLZO2018-11-28
837331365532827K181635GMK Sphere CR Tibial InsertsJWH2018-08-23
837331605988734K181254Quadra PLZO2018-10-22
837331810795826K181086Cortical Fixation SystemsMBI2019-01-09
837331562463224K180089Medacta Shoulder System Short Humeral DiaphysisPHX2018-04-05
837331750674584K173890GMK Sphere - Kinematic AlignmentJWH2018-08-23
837331802832808K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredLZO2018-03-14
837331463500979K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsPQC2018-04-19
837331058225860K173267MasterLoc Stem: Lateralized PlusLZO2017-12-07
837331983756076K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersODP2017-09-18
837331230563570K172347GMK Hinge, GMK RevisionKRO2017-11-01
837331881221331K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™LPH2018-03-27
837331472023260K171758M.U.S.T. Combined Set ScrewsNKB2017-08-01
837331234845174K171640M-ARS ACL: Anatomic Ribbon Surgery SystemMBI2017-10-23
837331018193297K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemOUR2017-08-02
837331944660282K171369M.U.S.T. MINI Posterior Cervical Screws SystemNKG2017-08-01
837331787693106K171058Medacta Shoulder System: Threaded Glenoid BaseplatePHX2017-12-13
837331509900030K170910Medacta Anatomic Shoulder ProsthesisKWS2017-08-16
837331213902167K170845MiniMAXLZO2017-08-08
837331123738609K170690M-Vizion Femoral Revision SystemLZO2017-11-29
837331786041823K170452Medacta Shoulder SystemPHX2017-10-05
837331477147071K1701493DMetal Tibial ConesJWH2017-08-18
837331834863950K170106MyKnee PPS-Pin PositionersJWH2017-10-20
837331045749691K041623REUSABLE STERILCONTAINER FILTER MODEL #JK090FRG2004-12-13
837331045227930
837331074508606
837331313630834
837331327609893
837331347215154
837331407033842
837331469695717
837331888010624

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZO112020-01-09
MBI82020-02-10
PHX62020-03-25
JWH52020-03-13
NKG42020-02-10
MAX22020-03-09
NKB22020-01-27
OUR22019-12-03
LPH22019-03-21
OVE12020-03-04
OVD12019-03-15
HSX12019-01-30
PQC12018-04-19
KRO12017-11-01
ODP12017-09-18
KWS12017-08-16
FRG12004-12-13