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

    ARCHITEX SPACE MAINTENANCE SYSTEM

    K Number: K110259 · Decision Apr 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    171
    Review Days
    75

    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
    ARCHITEX SPACE MAINTENANCE SYSTEM
    K Number
    K110259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Sofamor Danek USA, Inc.
    Date Received
    January 28, 2011
    Decision Date
    April 13, 2011
    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 Medtronic Sofamor Danek USA, Inc.

    K Number Device Name
    K253656 OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System
    K260216 CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System
    K254165 Infinity™ OCT System
    K253941 CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)
    K253335 CD Horizon™ Spinal System
    K253129 Infinity™ OCT System
    K251444 Endoskeleton™ Interbody Systems
    K251395 The Rialto™ SI Fusion System
    K250669 Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
    K241992 Catalyft™ LS Expandable Interbody System
    Search all 171 clearances from Medtronic Sofamor Danek USA, Inc. →