BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SURGICAL FUSION INC.

    Reg #: 3022472578 · FEI: 3022472578 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    SURGICAL FUSION INC.
    Registration Number
    3022472578
    FEI Number
    3022472578
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    930 Sylvan Ave, Suite 125
    City
    Englewood Cliffs
    State
    NJ
    ZIP
    07632
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171228

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

    Proprietary Names

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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198