BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DePuy Mitek, Inc.

    Reg #: 1221934 · FEI: 1221934 · Expires 2026
    View on FDA
    Products
    82
    Proprietary Names
    225
    Establishment Types
    1
    Classifications
    82

    Registration Details

    Registration Name
    DePuy Mitek, Inc.
    Registration Number
    1221934
    FEI Number
    1221934
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    325 Paramount Dr
    City
    RAYNHAM
    State
    MA
    ZIP
    02767
    Country
    US

    Regulatory Submissions

    510(k) Number
    K253791

    Owner / Operator

    Firm Name
    DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
    Operator Number
    1221934
    Address
    4600 Riverside Drive, --
    City
    Palm Beach Gardens
    State
    FL
    Postal Code
    33410
    Country
    US
    Correspondent
    Karen Parker

    Products

    Device Name Product Code
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Shoulder Prosthesis, Reverse Configuration PHX
    Pin, Fixation, Smooth HTY
    Pin, Fixation, Threaded JDW
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Screw, Fixation, Bone HWC
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Impactor HWA
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Prosthesis, Finger, Constrained, Polymer KYJ
    Staple, Fixation, Bone JDR
    Cannula, Surgical, General & Plastic Surgery GEA
    Retractor GAD
    Reamer HTO
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Arthroscope HRX
    Rasp HTR
    Washer, Bolt Nut HTN
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Forceps, General & Plastic Surgery GEN
    Cutter, Surgical FZT
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Kit, Surgical Instrument, Disposable KDD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Awl HWJ
    Table, Surgical With Orthopedic Accessories, Manual JEB
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Elevator, Surgical, General & Plastic Surgery GEG
    Screwdriver HXX
    Instrument, Cutting, Orthopedic HTZ
    Depressor, Orbital HNX
    Broach HTQ
    Laparoscope, General & Plastic Surgery GCJ
    Light Source, Fiberoptic, Routine FCW
    Orthopedic Manual Surgical Instrument LXH
    Prosthesis, Elbow, Constrained, Cemented JDC
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Bit, Surgical GFG
    Guide, Surgical, Instrument FZX
    Knife, Orthopedic HTS
    Chisel, Surgical, Manual FZO
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Stand, Infusion FOX
    Trephine HWK
    System, Irrigation, Urological LJH
    Resectoscope, Working Element FDC
    Bit, Drill HTW
    Gauge, Depth HTJ
    Light, Surgical, Connector FSX
    Scalpel, One-Piece GDX
    Wrench HXC
    Hammer, Surgical FZY
    Applier, Staple, Surgical, GEF
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Camera, Television, Endoscopic, Without Audio FWF
    Instrument, Ligature Passing And Knot Tying HCF
    Anchor, Suture, Bone Fixation, Metallic NOV
    Template HWT
    Goniometer, Nonpowered KQW
    Tamp HXG
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Light, Surgical, Fiberoptic FST
    Catheter, Infusion JCY
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Mallet, Surgical, General & Plastic Surgery GFJ
    Mesh, Surgical, Polymeric FTL
    Needle, Suturing, Disposable GAB
    Tap, Bone HWX
    Accessories, Arthroscopic NBH
    Clamp HXD
    Extractor HWB
    Osteotome HWM
    Rongeur HTX
    Driver, Prosthesis HWR
    Tray, Surgical, Instrument FSM
    Probe HXB

    Proprietary Names

    PUREVUE DELTA CTA Shoulder System SlingShot GLOBAL AP GLOBAL APG GLOBAL SHOULDER Biocryl Rapide Interference Screw HEALIX ADVANCE Anchor with DYNACORD Suture GLOBAL CAP BioFastin RC Anchor DELTA XTEND Reverse Shoulder System GLOBAL ADVANTAGE GLOBAL UNITE GLOBAL APG+ TALON ANCHOR SNAP-PAK NEUFLEX Fastin Anchor MULTIPLE CANNULAE FMS ARTHROSCOPY WORKING CANNULA Gryphon Anchor w/ProKnot Bio-Intrafix Screw/Sheath GLOBAL ENABLE Milagro/Milagro Advance Screw Anchor DePuy Mitek Instrument RIGIDFIX BTB Cross Pin Kit ROC P50 FMS Cannula RigidFix PLA GII QA+ w #2 Orthocord Clearfix Meniscal Screw Healix Advance Anchors with Permacord Suture Quickanchor HEALIX ADVANCE SP PEEK Anchor Rigidloop Titanium Button Rigidloop Cortical Fixation System XL Implant CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TIS Global Unite Platform Shoulder System duo+ and solo ARTHROSCOPE (MULTIPLE BRANDS) AGILITY RigidLoop RigidLoop Adjustable Cortical Fixation System Super Anchor Healix Ti HEALIX ADVANCE Knotless Anchors HEALIX ADVANCE Self-Punching Anchors Screw RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM GII ROC EZ PERMATAPE SUTURE CUTTER Milagro Interference Screws Gryphon Anchors MiniROC SINUSCOPE Healix Advance Knotless BR Anchor Rigidloop Disposable Kit GLOBAL STEPTECH RigidFix Biocryl Cross Pin Kit INHANCE Shoulder System VAPR II Generator & TC Electrode Gryphon T and P BR Anchors GRYPHON™ Flex Knotless PEEK Anchor GRYPHON™ Flex Knotless Biocomposite Anchor Vapr Vue Generator, Vapr 3 Electrosurgical GRYPHON Anchors with DYNACORD Suture Bioknotless Plus Lupine Loop Plus Anchor STRICKLAND ORTHOCORD SUTURE SUTURE PERIOSTEAL ELEVATOR FMS VUE system FMS Interface Cable Duo/Solo RapidLoc RIDIDFIX Omnispan Meniscal Repair System Gryphon P BR Single and Double Arm Meniscal Needles GLOBAL FX BIOROC EZ SUTURE BONE FASTENER VAPR Electrode w/Integrated Handpiece RC ARTHROSCOPE GLOBAL UNITE Platform Shoulder System Short Stem Mitek MILAGRO ADVANCE Screw OMNICUT Resection Blade Permaloop Suture Permatape Suture Milagro Advance PEEK ORBITAL BOLT MULTIPLE WASHER NUT Fastin RC 2.3mm Side Effect Electrode FMS VUE™ Healix PEEK Femoral Intrafix System Electrode, Foot Pedal, Pump, Remote Control Versalok Pre-packed W/Orthocord Healix Advance Knotless PEEK Anchor RIGIDFIX Curve CANNULATED CROSS PIN SCREW SYSTEM ELECTROSURGICAL SYSTEM HEALIX TI™ 3 SUTURE ANCHOR with DYNACORD™ HEALIX TI™ ANCHOR with DYNACORD™ HEALIX TI™ ANCHOR with DYNACORD™ AND NEEDLES Latarjet Panalok Loop Bristow Latarjet BIODHOC OVS1 Video System Panalok RC Dual Suture ACCLAIM GRYPHON X Anchor HEALIX TRANSTEND Anchor Camera Control System with Light Source and Light Guides Minilok QA+ ADHOC CLAW HEALIX ADVANCE PEEK ANCHOR Abs. Micro QA+ Healix Advance IDEAL Suture Shuttle, Suture Grasper, Knot Manipulator, Suture Leader Caddy FASTIN RC ANCHOR Gryphon Mini QA+ Healix BR Anchor, Healix PEEK Anchor, Healix Transtend and more. CuffTack HEALIX ADVANCE Anchor with PERMATAPE Suture MITEK DRILL GUIDE MULTIPLE GUIDES Gryphon Anchor w/ProKnot Technology PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM Orthocord TIGHT-N Tendon Docking Anchor HEALIX ADVANCE SP BIOCOMPOSITE Anchor Mini Anchor Mini Quick Anchor Plus Drill bit Arthroscopic Equipment Cart Truespan Shoulder instruments Gryphon T BR Spiralok IRRIGATION UROLOGICAL(MULTIPLE) MITEK DRILL FIXATION SCREW BONE(MULTIPLE BRANDS) Bioknotless Rapide Lupine Loop Rapide DEPTH GUAGE Light Adaptor ACL GRAFT KNIVES GRAFT KNIVES HEALIX ADVANCE PEEK Anchor with DYNATAPE Suture HD Arthroscope Healix TransTend Anchors INTRAFIX Advance VAPR ARCTIC Suction Electrode Vapr "T" Electrode Mitek QuickAnchor INSERTER MITEK INSERTERS Healix Advance Anchors with Dyna+Tape Sutures RC/GII Super Anchor - Orthocord VAPR 2.3mm Wedge Electrode MULTIPLE ANCHORS Biocryl Interference Screws Laparoscopes Camera Control Unit and Camera Head Healix Advance Knotless MITEK KDI MULTIPLE SUTURE GRASPER KNOT PUSHER MicroFix QA+ Micro QA+ VAPR 2.3mm End Effect Electrode ADVANTAGE FIXATION SCREW SYSTEM Panalok MICRO QUICKANCHOR TIBIAL FIXATION FASTENER MENISCAL DART REPAIR SYSTEM DYNATAPE Suture Healix Ti anchor with Permacord suture LinX HT Absolute Absorbable Coupler Light Guide Fluid delivery tubing Tubing DELTA XTEND Intrafix PEEK Tapered Screw Global Shoulder Tube Set, Shaver Blades, Cutter, Cutter Shaver, Burr, Hand Control Interface, Foot Pedal, Tube Set. VAPR S50 Electrode VAPR P50 Electrode with Handcontrols VAPR S90 Electrode with Handcontrols VAPR P50 Electrode VAPR S90 Electrode Milagro Interference Screw RigidFix Biocryl Milagro Advance Interference Screw Cuff Link FMS VUE II Fluid Management and Tissue Debridement System Healix Knotless PEEK Anchor EYED NEEDLE Orthocord - Blue Arthroscopic Instruments TROCARS, SHEATHS, OBTURATORS DYNACORD Suture S90 Electrode with Handcontrols HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture GLOBAL ICON Intrafix Tibial Sheath VAPR VUE Radiofrequency System MITEK STERILIZATION TRAY STERILIZATION TRAY FMS PROBE

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility