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

    KLS Martin Individual Patient Solutions

    K Number: K210731 · Decision Jul 18, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    58
    Review Days
    494

    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
    KLS Martin Individual Patient Solutions
    K Number
    K210731
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KLS-Martin L.P.
    Date Received
    March 11, 2021
    Decision Date
    July 18, 2022
    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 KLS-Martin L.P.

    K Number Device Name
    K253660 KLS Martin Pure Pectus System
    K250988 KLS Martin Pure Pectus System
    K250865 KLS Martin IPS Forearm System
    K252573 KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
    K233721 KLS Martin Drill-Free MMF Screw
    K241314 KLS Martin Oral-Max Implants MR Conditional (bundled)
    K241018 KLS Martin Orthopedic Implants - MR Conditional
    K230211 CranioXpand
    K222624 KLS Martin LINOS Wrist System
    K222397 KLS Martin Level One Rib Fixation System
    Search all 58 clearances from KLS-Martin L.P. →