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510(k) Data Aggregation

    K Number
    K231030
    Device Name
    Cove Putty, OsteoCove Putty
    Manufacturer
    SeaSpine Orthopedics Corporation
    Date Cleared
    2023-09-14

    (156 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K140375,K062353,K212135
    Why did this record match?
    Reference Devices :

    K140375, K062353, K212135

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cove Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Cove Putty is hydrated with saline at the point-of-use.

    OsteoCove Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. OsteoCove Putty is hydrated with saline at the point-of-use.

    Device Description

    Cove Putty is formulated into a putty which consists of a collagen scaffold containing ceramic granules and a resorbable polymer carrier throughout. The combined collagen and ceramic provide osteoconductive substrates that support new bone formation. Cove Putty combined with autograft in a 1:1 ratio is intended to be placed in the posterolateral spine. The implant is provided sterile and non-pyrogenic for single use in a standard syringe.

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for two bone void fillers, Cove Putty and OsteoCove Putty. As such, it does not contain the information requested about acceptance criteria and study data for an AI/ML powered device.

    The document states:

    • "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." on page 6.

    Therefore, I cannot provide the requested information, which pertains to the validation of AI/ML devices. The 510(k) summary focuses on non-clinical testing (biocompatibility, bacterial endotoxin, sterilization, and an in vivo animal study) to demonstrate substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for an AI/ML algorithm.

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