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

    NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR

    K Number: K021342 · Decision Aug 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    9
    Review Days
    94

    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
    NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
    K Number
    K021342
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteomedics, Inc.
    Date Received
    April 29, 2002
    Decision Date
    August 1, 2002
    Product Code
    JEY
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JEY Plate, Bone

    Similar 510(k) Clearances

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

    Leforte MMF System

    FDA 510(k)
    FDA Class 2 ·Dental

    Southern Craniomaxillofacial (CMF) System

    FDA 510(k)
    FDA Class 2 ·Dental

    Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System

    FDA 510(k)
    FDA Class 2 ·Dental

    KLS Martin Oral-Max Implants MR Conditional (bundled)

    FDA 510(k)
    FDA Class 2 ·Dental

    MRI Universal

    FDA 510(k)
    FDA Class 2 ·Dental

    tmCMF Solution

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

    Other Clearances by Osteomedics, Inc.

    K Number Device Name
    K022035 OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
    K022324 NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
    K022231 NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
    K022230 NORMED MINI EXTERNAL FIXATOR SYSTEM
    K022323 NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
    K022325 NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
    K021341 NORMED BONE TRANSPORT DISTRACTION DEVICE
    K010118 NORMED MANDIBULAR FIXATION SYSTEM