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

    UNIVERSAL DRIVE SYSTEM

    K Number: K971059 · Decision Jun 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    93
    Review Days
    86

    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
    UNIVERSAL DRIVE SYSTEM
    K Number
    K971059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Linvatec Corp.
    Date Received
    March 24, 1997
    Decision Date
    June 18, 1997
    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 Linvatec Corp.

    K Number Device Name
    K092998 CONMED LINVATEC INTERCEPT IMPLANT
    K091549 CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM
    K090835 CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR
    K090186 CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES
    K083281 EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-
    K060198 MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW
    K060260 MICROPOWER HAND PIECE HIGH SPEED DRILL
    K060270 MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
    K050519 ADVANCED TURBO DRIVE SYSTEM
    K050497 BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET
    Search all 93 clearances from Linvatec Corp. →