BEUDAMED
    FDA Registration Active 🇫🇷 France

    RIGIDLOOP™ Suture Loop, Catalog Number 232484

    Reg #: 3004549189 · FEI: 3004051158 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SCIENCE & BIO MATERIALS, S.B.M. SAS
    Registration Number
    3004549189
    FEI Number
    3004051158
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ZI DU MONGE
    City
    LOURDES Hautes-Pyrenees
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K202193

    Owner / Operator

    Firm Name
    SCIENCE & BIO MATERIALS
    Operator Number
    9063735
    Address
    S.B.M. SAS - ZI DU MONGE, --
    City
    Lourdes
    State
    Hautes-Pyrenees
    Postal Code
    65100
    Country
    FR
    Correspondent
    Anne - COSPIN

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th Street, Suite 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    RIGIDLOOP™ Suture Loop, Catalog Number 232484 RIGIDLOOP™ BTB Adjustable Cortical System - Standard, Catalog Number 232485 RIGIDLOOP™ Clip Cortical Button - XL, Catalog Number 232483 PULLUP® TEX CLIP Adjustable fixation system for ligament reconstruction - loop only, Catalog Number PULL00LOOP BT LOOP® Adjustable fixation system for ligament reconstruction, tunnel diam. 4.5mm, Catalog Number BTB0001709 RIGIDLOOP™ Clip Cortical Button - Standard, Catalog Number 232482 PULLUP® BTB Adjustable fixation system for ligament reconstruction - tunnel diam. 4.5mm, Catalog Number PULLUK1201 PULLUP® CLIP connectable plate - tunnel diam. 4.5mm, Catalog Number PULL0CT201 PULLUP® XL CLIP connectable plate - tunnel diam. 5-10mm, Catalog Number PULXLCT202 RIGIDLOOP™ BTB Adjustable Cortical System - XL, Catalog Number 232486 BT LOOP® XL Adjustable fixation system for ligament reconstruction, tunnel diam. 5-10mm, Catalog Number BTBXL01709 PULLUP® BTB XL Adjustable fixation system for ligament reconstruction - tunnel diam. 5-10mm, Catalog Number PULXLK1202

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device