BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORTHONOVIS, INC.

    Reg #: 3015946784 · FEI: 3015946784 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    15
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    ORTHONOVIS, INC.
    Registration Number
    3015946784
    FEI Number
    3015946784
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 Hargrove Grade Ste 4
    City
    Palm Coast
    State
    FL
    ZIP
    32137
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191641

    Owner / Operator

    Firm Name
    OrthoNovis, Inc.
    Operator Number
    10061543
    Address
    1 Hargrove Grade, 2F
    City
    Palm Coast
    State
    FL
    Postal Code
    32137
    Country
    US
    Correspondent
    Ken West

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Rod, Fixation, Intramedullary And Accessories HSB
    Pin, Fixation, Threaded JDW
    Nail, Fixation, Bone JDS
    Pin, Fixation, Smooth HTY
    Wound Dressing With Animal-Derived Material(S) KGN
    Washer, Bolt Nut HTN
    Filler, Bone Void, Calcium Compound MQV
    Staple, Fixation, Bone JDR
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Mixer, Blood Tube GLE

    Proprietary Names

    BPSS Affinity Wrist Fracture System IONz IntraHeal Trochanteric Fixation System CSM NoviCoid AC Joint Repair System BPSS Foot Plating System OrthoNovis Bone Plate and Screw System BPS Wrist Fracture System BTB Bone Graft Putty BPSS Memory Metal Staple System OrthoNovis BPSS Cannulated Screws Cannulated Screw and Kirschner (K wire) System BPS Bone Fragment Fixation Plates, Screws and Washers ONX Large External Fixation System Orthonovis CPS Orthonovis STS

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device