BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CENTINEL SPINE, LLC

    Reg #: 3007494564 · FEI: 3007494564 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    CENTINEL SPINE, LLC
    Registration Number
    3007494564
    FEI Number
    3007494564
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    900 Airport Rd Ste 3B
    City
    West Chester
    State
    PA
    ZIP
    19380
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242869
    PMA Number
    P070001

    Owner / Operator

    Firm Name
    Centinel Spine, LLC
    Operator Number
    10026981
    Address
    900 Airport Rd, Suite 3B
    City
    West Chester
    State
    PA
    Postal Code
    19380
    Country
    US
    Correspondent
    Jessica D Staub

    Products

    Device Name Product Code
    Prosthesis, Intervertebral Disc MJO
    Rongeur HTX
    Rasp HTR
    Awl HWJ
    Manual Instruments Designed For Use With Total Disc Replacement Devices QLQ
    Orthopedic Manual Surgical Instrument LXH
    Tray, Surgical, Instrument FSM
    Tray, Surgical LRP

    Proprietary Names

    Prodisc C Prodisc L Stalif C Rongeur Stalif Lumbar Rasp, Various sizes Stalif C Tapered Rasp, Various sizes Stalif Midline Lumbar Stem Rasp, Various sizes STALIF C Flexible Awl Guide, Various Sizes STALIF Midline Flexible Awl Guide, Various Sizes STALIF TT Flexible Awl Guide, Various sizes Prodisc L Total Disc Replacement Manual Instruments STALIF C trial sizers - Various sizes STALIF C Instrument case system Stalif Midline Instrument Tray STALIF Midline Auxiliary Tray Stalif Midline Trials Tray Prodisc C Vivo Prodisc C SK Prodisc C Nova

    Establishment Types

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