BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CALVARY SPINE, LLC

    Reg #: 3007279845 · FEI: 3007279845 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    CALVARY SPINE, LLC
    Registration Number
    3007279845
    FEI Number
    3007279845
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    308 North Wind Rd.
    City
    Towson
    State
    MD
    ZIP
    21204
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082260

    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
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Thoracolumbosacral Pedicle Screw System NKB
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Calvary Lumbar Interbody Spacers/ Fusion Device (crescent & straight-shaped interbody cages; 7-15mm heights) Calvary Cervical Interbody Spacers/ Fusion Device (standard & large footprint interbody cages; 5-9mm heights) Extra Small, Small, Medium, and Large Variable Crosslinks Pre Lordosed Rod 5.5mm Diameter 30mm - 100mm lengths made from Ti6Al4V, CP Titanium, or CoCr Calvary Spine Pedicle Screw System Polyaxial Screw, Reduction Screws, & Cannulated Polyaxial Screws: 5.5mm, 6.5mm, 7.5mm, & 8.5mm dia in 25-90mm length Iliac Connector 5.5mm Diameter 30mm & 50 mm rod lengths Locking cap for Polyaxial screws Straight Rod 5.5mm Diameter 240mm or 480mm lengths made from Ti6Al4V, CP Titanium, or CoCr 23mm, 24mm, 25mm, 26mm, 27mm, 28mm Fixed Crosslinks Cervical Instruments: 5-9mm trials, 5-9mm dual head trials, rasp, tamp, mallet, inserter, caddy, instrument tray & lid Lumbar Instruments: 6mm distractor, 7-15mm shaver, caddy, tray & lid Lumbar Instruments: 7-15mm straight & crescent trials, implant inserter with locking rod, cup & uterine curettes

    Establishment Types

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