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

    Curiteva Porous PEEK Cervical Interbody Fusion System

    K Number: K254061 · Decision Jan 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    11
    Review Days
    29

    Basic Information

    Device Name
    Curiteva Porous PEEK Cervical Interbody Fusion System
    K Number
    K254061
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Curiteva, Inc.
    Date Received
    December 17, 2025
    Decision Date
    January 15, 2026
    Product Code
    ODP
    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

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    Other Clearances by Curiteva, Inc.

    K Number Device Name
    K252205 Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System
    K250845 Curiteva Porous PEEK Standalone ALIF System
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    K233744 Curiteva Porous PEEK Lumbar Interbody Fusion System
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    K213030 Curiteva Porous PEEK Cervical Interbody Fusion System
    K223200 Curiteva Navigation System
    K210402 Curiteva Sacroiliac Joint Fusion System
    K191810 Curiteva Pedicle Screw System
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