BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medartis Inc.

    Reg #: 3009540749 · FEI: 3009540749 · Expires 2026
    View on FDA
    Products
    44
    Proprietary Names
    77
    Establishment Types
    5
    Classifications
    44

    Registration Details

    Registration Name
    Medartis Inc.
    Registration Number
    3009540749
    FEI Number
    3009540749
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1195 Polk Drive
    City
    Warsaw
    State
    IN
    ZIP
    46582
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212979
    PMA Number
    P240020

    Owner / Operator

    Firm Name
    MEDARTIS AG
    Operator Number
    9033581
    Address
    HOCHBERGERSTRASSE 60E, --
    City
    BASEL
    State
    Basel-Stadt
    Postal Code
    CH-4057
    Country
    CH

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Orthopedic Manual Surgical Instrument LXH
    Bone Wedge PLF
    Tap, Bone HWX
    Rod, Fixation, Intramedullary And Accessories HSB
    Gauge, Depth HTJ
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Interlaminal KWP
    Rasp, Surgical, General & Plastic Surgery GAC
    Hook, Bone KIK
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Pin, Fixation, Smooth HTY
    Washer, Bolt Nut HTN
    Bit, Surgical GFG
    Tape, Measuring, Rulers And Calipers FTY
    Staple, Fixation, Bone JDR
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Tray, Surgical, Instrument FSM
    Impactor HWA
    Osteotome HWM
    Guide, Surgical, Instrument FZX
    Passer HWQ
    Starter, Bone Screw HWD
    Clamp HXD
    Probe HXB
    Awl HWJ
    Bender HXW
    Prosthesis, Finger, Semi-Constrained, Metal/Polymer SFA
    Retractor GAD
    Bracket, Metal, Orthodontic EJF
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Tray, Surgical LRP
    Bit, Drill HTW
    Protractor HTH
    Screwdriver HXX
    Extractor HWB
    Stylet, Surgical, General & Plastic Surgery GAH
    Guide, Needle, Surgical GDF
    Chisel, Surgical, Manual FZO
    Driver, Surgical, Pin GFC
    Instrument, Bending Or Contouring HXP
    Mallet HXL
    Blade, Saw, General & Plastic Surgery, Surgical GFA

    Proprietary Names

    CalcShift Displacement Calcaneal Osteotomy System CalcShift Instrument System APTUS Foot 2.8-3.5 System APTUS Elbow Dorsal Olecranon Plates APTUS Hand System PediFrag Response Spine OrthoPediatrics PediNail Intramedullary Platform PediNail APTUS Ulna Shortening 2.5 OrthoPediatrics Cannulated Screw System APTUS Wrist Arthrodesis Plates DFOS APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System SCFE PNP StealthFix PEDINAIL INTRAMEDULLARY NAILING SYSTEM APTUS 2 Radial Head System APTUS Forearm APTUS K-Wire System Case Box Avenger Radial Head System Modul Rack Dispenser Container PediFlex Tray APTUS Distal Humerus System APTUS and MODUS Instruments PSN Drop Rod Adapter Lapidus Cut Guide Disposable Set Lapidus Cut Guide Patella Clamp Head PediLoc Lapiprep Lapidus Preparation System Cannulated Screws LCB StealthFix Intraosseous Fixation System BandLoc KeriFlex Instrumentation PediFoot APTUS Ulna Plates APTUS Wrist 2.5 System APTUS Foot 3.5 System Micro Screw Non-Sterile APTUS 2/2.3 Four Corner Fusion Plate Cannulated Screws Gen II PediPlates MPFL APTUS CMC-I Fusion Plate System APTUS Titanium Fixation System Touch CMC 1 Prosthesis Instruments TTS-Titanium Trauma Splint Titanium Arch Bar TTS Tooth Splint APTUS Proximal Humerus System APTUS Clavicle APTUS Coronoid 2 APTUS 1.5 TriLock PediFlex Flexible Nail System APTUS and MODUS Drill Bits Response Spine System APTUS Foot System Staple All-in-One Olive K-Wire Guide CAPTURED SCREW DRIVER SHAFT, 3.5MM, AO, LONG TAPERED SCREW DRIVER, 3.5MM, AO, LONG APTUS Shoulder Proximal Humerus System, PentaLock 3.5 APTUS Ankle Trauma System 2.8/3.5 OrthoPediatrics PediFoot Deformity Corrections System APTUS Wrist Arthrodesis APTUS Cannulated Compression Screws APTUS Cannulated Compression Screws 5/7 NX Nail Non-Sterile

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility