BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pre Lordosed Rod 5.5mm Diameter 30mm - 100mm lengths made from Ti6Al4V, CP Titanium, or CoCr

    Reg #: 3007279845 · FEI: 3007279845 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CALVARY SPINE, LLC
    Registration Number
    3007279845
    FEI Number
    3007279845
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    308 North Wind Rd.
    City
    Towson
    State
    MD
    ZIP
    21204
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201568

    Owner / Operator

    Firm Name
    Calvary Spine, LLC
    Operator Number
    10027607
    Address
    308 North Wind Rd.
    City
    Towson
    State
    MD
    Postal Code
    21204
    Country
    US

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    Pre Lordosed Rod 5.5mm Diameter 30mm - 100mm lengths made from Ti6Al4V, CP Titanium, or CoCr Extra Small, Small, Medium, and Large Variable Crosslinks Iliac Connector 5.5mm Diameter 30mm & 50 mm rod lengths Calvary Spine Pedicle Screw System 23mm, 24mm, 25mm, 26mm, 27mm, 28mm Fixed Crosslinks Straight Rod 5.5mm Diameter 240mm or 480mm lengths made from Ti6Al4V, CP Titanium, or CoCr Locking cap for Polyaxial screws Polyaxial Screw, Reduction Screws, & Cannulated Polyaxial Screws: 5.5mm, 6.5mm, 7.5mm, & 8.5mm dia in 25-90mm length

    Establishment Types

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