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

    KYPHON INFLATABLE BONE TAMP

    K Number: K981251 · Decision Jul 2, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    9
    Review Days
    87

    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
    KYPHON INFLATABLE BONE TAMP
    K Number
    K981251
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kyphon, Inc.
    Date Received
    April 6, 1998
    Decision Date
    July 2, 1998
    Product Code
    HRX
    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
    HRX Arthroscope

    Similar 510(k) Clearances

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

    Digital ClarusScope System and Digital NeuroPEN System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Freedom DS™ Decompression System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VantageTM Lumbar Decompression Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PUREVUE™ FMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Articulator Arthroscopic Bur

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

    Other Clearances by Kyphon, Inc.

    K Number Device Name
    K073516 DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR
    K063071 DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B
    K061210 FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B
    K041454 KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
    K041584 KYPHX HV-R BONE CEMENT, MODEL C01A
    K033801 KYPHX HV-R, MODEL C01A
    K032212 KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
    K010246 KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A