BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOPRO, INC.

    Reg #: 1833506 · FEI: 1832656 · Expires 2026
    View on FDA
    Products
    45
    Proprietary Names
    109
    Establishment Types
    3
    Classifications
    45

    Registration Details

    Registration Name
    BIOPRO, INC.
    Registration Number
    1833506
    FEI Number
    1832656
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2929 Lapeer Rd
    City
    PORT HURON
    State
    MI
    ZIP
    48060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K964472

    Owner / Operator

    Firm Name
    BIOPRO, INC.
    Operator Number
    9001497
    Address
    2929 Lapeer Rd., --
    City
    Port Huron
    State
    MI
    Postal Code
    48060
    Country
    US
    Correspondent
    Kimberly - Light

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Wrist, Carpal Trapezium KYI
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Bit, Drill HTW
    Screw, Fixation, Bone HWC
    Pin, Fixation, Smooth HTY
    Osteotome, Manual GFI
    Shoulder Prosthesis, Reverse Configuration PHX
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Extractor HWB
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Washer, Bolt Nut HTN
    Gauge, Depth HTJ
    Bone Wedge PLF
    Plate, Fixation, Bone HRS
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Staple, Fixation, Bone JDR
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Pin, Fixation, Threaded JDW
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Thoracolumbosacral Pedicle Screw System NKB
    Orthopedic Stereotaxic Instrument OLO
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Instrument, Bending Or Contouring HXP
    Orthopedic Manual Surgical Instrument LXH
    Screwdriver HXX
    Retractor GAD
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Instrument, Compression HWN
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Prosthesis, Hip, Femoral, Resurfacing KXA
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Tray, Surgical, Instrument FSM
    Reamer HTO
    Guide, Surgical, Instrument FZX
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Template HWT
    Apparatus, Air Handling, Room FZH
    Knife, Surgical EMF
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    0 Degree Bipolar Liners BIOPRO MODULAR THUMB IMPLANT iNSitu Bipolar Hip System BREAK OUT TruTrack Sterile Drills BioPro Sterile Drills Orthonovus Sterile Drills HBS Non-Sterile Screw System Sterile K-wire Osteotomes Sevin Reverse Shoulder Tyber Medical Trauma Screw Sterile Spine ACP System iNSitu Head Extractor Hemi Endo Femoral Head BioPro Tendon Anchor System Depth Gauge Wedge System Wedge System, Fixation Plate Wedge System, Fixation Screw Wedge System, Bone wedge INnate Cannulated Screw System (*306 BioPro Anatomic Unicompartmental Knee System B-P Hip Acetabluar Bearing IngenTotal Shoulder System KORONA Staple System Clover Staple BioPro Ceramic Femoral Head B-P Hip Acetabluar Components Go-EZ Screw GO-EZ SimpliFix Hip Fixation System Digital Compression Screw Tyber Medical PT Interbody Spacer Modular Thumb PS SERPENS CMC Implant System B-P Shoulder Humeral Resurfacing Head Ingenix Ingenix Polyaxial Deformity Screw Kit KneeAlign 2 UniAlign KA2 iNSitu Total Hip System INFrame Bending Iron BioPro Femoral Head BIOPRO SURGICAL INSTRUMENTS iNSitu Bipolar Head Trials Carina Memory Staple TRUTRACK MEMORY STAPLE MaxxHealth Memory Staple OrthoNovis Memory Staple MEMORY STAPLE Screwdriver Nano Screws Hintermann Compressor Hintermann Distractor WishBone Bone Plates and Screws BioPro Hemi-Edge Toe System Effi+Pro Single Use Compression/Distraction Kit Tyber Medical Interbody System Tyber Medical TLIF Tyber Medical OLIF Tyber Medical PLIF Tyber Medical DLIF Tyber Medical ALIF Tyber Medical ACIF Harvey Surgical Assistant System BioPro PSL Total Hip System ArcPhix ArrowPhix King Cobra Anterior Cervical Plate OrthAlign HipAlign Cox Comb Cup B-P Hip Femoral Components B-P HIP ACETABULAR FIXATION CUP W/BIOCOAT & W/ULTRACOAT VOLANS Lesser MPJ Hemi Implant System NAOS First MPJ Hemi Implant System First MPJ Implant Monogram mBos TKA System BioPro Endo Modular Ceramic OrthAlign Sterile Pin Pack Bipolar Femoral Component Surgical Instrument Tray PSL Hip System BioPro Femoral Heads Horizon Subtalar CORVUS Subtalar Implant System HBS Headless Bone Screw HBS Reamer BIOPRO MODULAR THUMB IMPLANTS Klassic BiPolar System BiPolar Head PURE-CUT ACCU-CUT Total Knee Modular Tibial Tray Femur Plate Template Townley Total Knee TARA Resurfacing Component Providence Cup System Tyber Medical PT Interbody Spacer System BioPro Foot Plating System BPSS Foot Plating System INnate Cannulated Screw (4.5) 10 Degree Bipolar Liners iNSitu Bipolar Sizing Ring Assembly Fasciotome Shotel Nail APEX Hip

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device