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    FDA Registration Active 🇺🇸 United States

    TP.IN012 Gervical Awl

    Reg #: 3015426608 · FEI: 3015426608 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    41
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Medynus, Inc.
    Registration Number
    3015426608
    FEI Number
    3015426608
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    18 Technology Dr. Suite 109
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220379

    Owner / Operator

    Firm Name
    Medynus, Inc.
    Operator Number
    10060045
    Address
    18 Technology Dr. Suite 109
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Daewon Shin

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    TP.IN012 Gervical Awl Cervical Plate 5 level Implant Caddy (CPR-00007) Fixed Awl (CPN-00003) CERVICAL PLATE IMPLANTS CONTAINER (CPT-00001, AICN-1005-0002, and others) Drill Guide Variable (CPN-00011) Drill bit 16 (CPN-00008) Drill bit 20 (CPN-00010) Drill bit 14 (CPN-00007) Cervical Plate tap (CPN-00004) Cervical plate torque limit driver (CPN-00019) Drill bit 12 (CPN-00006) Cervical Plate Container (CPT-00001) Cervical Plate Screw Implant Caddy (CPR-00002) Prefixation Pin (CPN-00001) Plate bender (CPN-00016) Cervical Plate 3 level Implant Caddy (CPR-00005) CPN-00007 (TP.IN008) Drill bit - 14 mm CPN-00001 Temporary Fixation pin CPN-00006 (TP.IN007) Drill bit - 12 mm CPN-00011 (TP.IN004) Variable angle Drill Guide (single barrel)-like Uniplate CPN-00016 (TP.IN003) Plate bender Cervical Plate 1 level Implant Caddy (CPR-00003) CCN-00053 (AC100) Cervical Bone packing bar Drill Guide Fixed (CPN-00012) Drill Guide Dual (CPN-00013) Drill bit 18 (CPN-00009) Modular I handle for Cervical (CPN-00014) Punch Awl (CPN-00002) Cervical plate screw driver ball (CPN-00017) Cervical Plate 4 level Implant Caddy (CPR-00006) Cervical plate screw driver centerline (CPN-00018) Drill bit 10 (CPN-00005) Cervical Plate 2 level Implant Caddy (CPR-00004) Plate holder (CPN-00015) CPN-00005 (TP.IN006) Drill bit - 10 mm CPN-00003 (TP.IN013) Cervical Fixed Awl, for Drill Guide CPN-00017 (CD.TP.IN014) Cervical plate screw driver ball shaft CPN-00014( CD.TP.IN005) A-O Quick Connect Handle, Swivel_Short Type CPN-00015 (TP.IN002) Plate holder CPN-00012 (TP.IN005) Fixed pre-set angle Drill Guide (single barrel) CPN-00002 (TP.IN012) Cervical Punch Awl with Sleeve

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198