BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD

    K Number: K993873 · Decision Jan 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    20
    Review Days
    49

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
    K Number
    K993873
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alphatec Mfg., Inc.
    Date Received
    November 15, 1999
    Decision Date
    January 3, 2000
    Product Code
    KTT
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KTT), ordered by most recent decision date.

    MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYNEX® External Fixation Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QuikFix External Fixator: Knee-Spanning Pack

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Excelsior System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hoffmann LRF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Monkey Rings External Ring Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Alphatec Mfg., Inc.

    K Number Device Name
    K033090 ICON POLYAXIAL PEDICLE SCREW SYSTEM
    K023299 ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
    K020356 ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
    K993513 DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
    K992350 PYLON INTRAMEDULLAARY NAIL SYSTEM
    K980788 ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
    K964400 ALPHATEC EXTERNAL FIXATION SYSTEM
    K951846 MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS
    K926417 ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW
    K930515 ALPHA SPINAL SYSTEM
    Search all 20 clearances from Alphatec Mfg., Inc. →