BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ANTERIOR SPINAL FIXATION PLATE

    K Number: K870085 · Decision Jun 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    9
    Review Days
    173

    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
    ANTERIOR SPINAL FIXATION PLATE
    K Number
    K870085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Terray Manufacturing, Inc.
    Date Received
    January 8, 1987
    Decision Date
    June 30, 1987
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

    Similar 510(k) Clearances

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

    LnK Posterior Cervical Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OASYS System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sure Lok Mini Posterior Cervical/Upper Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Reliance Posterior Cervical-Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Streamline OCT Occipito-Cervico-Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLSTICE OCT System

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

    Other Clearances by Terray Manufacturing, Inc.

    K Number Device Name
    K910874 THORACIC ANTERIOR SPINAL FIXATION PLATE
    K882934 CASF CANCELLOUS BONE SCREW, BT650
    K882871 CASF DRILL GUIDE DG 170
    K883125 CASF STERILIZATION TRAY
    K883193 CASF STERILIZATION TRAY
    K870082 BONE PLATE
    K870083 FERRAY EXTRACTOR
    K870084 RD 140 SURGICAL BENDER