BEUDAMED
    Product Code: OWX FDA class 2 21 CFR 878.3300

    Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

    General, Plastic Surgery

    The Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement of Tendon is a non-absorbable surgical mesh implant used for reinforcement of soft tissue where weakness exists during tendon repair procedures. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OWX, with regulation number 878.3300, reviewed under the orthopedic panel within the General, Plastic Surgery specialty, and it carries an implant flag.

    View on FDA
    510(k)s
    5
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    3
    Years Active
    2

    Research product code OWX in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    OWX
    Device Class
    FDA class 2
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    For reinforcement of soft tissue where weakness exists in tendon repair.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 5 510(k) clearances via K numbers.

    K Number Device Name
    K253867 FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit
    K250997 Integrity™ Implant
    K243480 SuturePatch Tissue Reinforcement
    K241219 FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
    K223538 Integrity Implant

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.