BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRO SURGICAL, INC.

    Reg #: 3031081659 · FEI: 3031081659 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    PRO SURGICAL, INC.
    Registration Number
    3031081659
    FEI Number
    3031081659
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1910 Palomar Point Way, Suite 201
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242517

    Owner / Operator

    Firm Name
    Pro Surgical, Inc.
    Operator Number
    10090745
    Address
    1910 Palomar Point Way, Suite 201
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Jason Blain

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    ProAM ALIF System Pro Surgical Orthopedic manual instruments

    Establishment Types

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