BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Guide S-PI / W5

    Reg #: 3022472578 · FEI: 3022472578 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    SURGICAL FUSION INC.
    Registration Number
    3022472578
    FEI Number
    3022472578
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    930 Sylvan Ave, Suite 125
    City
    Englewood Cliffs
    State
    NJ
    ZIP
    07632
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240288

    Owner / Operator

    Firm Name
    Surgical Fusion Inc.
    Operator Number
    10084995
    Address
    930 Sylvan Ave, Suite 125
    City
    Englewood Cliffs
    State
    NJ
    Postal Code
    07632
    Country
    US
    Correspondent
    Till Gumz

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Pin, Fixation, Smooth HTY
    Screw, Fixation, Bone HWC
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Fastener, Fixation, Biodegradable, Soft Tissue MAI

    Proprietary Names

    Guide S-PI / W5 SF Push-in Anchor 2.3 Tray SF Push-in Anchor Portfolio SF Push-in Anchor 3 Drill PI-S-A2.3 Stopper S-PI-A3 Handpiece Front Cover Drill PI-S-A3 SupraFuser Handpiece Sonotrode S-PI Stopper S-PI-A1.6 SF Push-in Anchor 1.6 Stopper S-PI-A2.3 SupraFuser Ultrasonic Generator Drill PI-S-A1.6

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198