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510(k) Data Aggregation

    K Number
    K242895
    Device Name
    Aevumed PHANTOM Suture Anchors
    Manufacturer
    Date Cleared
    2025-08-06

    (317 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aevumed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K223878
    Device Name
    Aevumed RAPID Suture Anchors
    Manufacturer
    Date Cleared
    2023-03-17

    (80 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aevumed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aevumed RAPID™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular repair, Acetabular Labral Repair
    Device Description
    The Aevumed RAPIDTM Suture Anchor with HS FiberTM suture is a suture anchor manufactured from polyetheretherketone (PEEK) material preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed RAPIDTM Suture Anchors are available in diameter sizes: 2.4mm and 3.0mm. They are offered sterile and are for single use only
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    K Number
    K222363
    Device Name
    Aevumed PHANTOM™-LP Suture Anchors
    Manufacturer
    Date Cleared
    2022-11-28

    (116 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aevumed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K180464
    Device Name
    AEVUMED PHANTOM Suture Anchors
    Manufacturer
    Date Cleared
    2018-05-31

    (99 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aevumed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aevumed PHANTOM™ suture anchors are intended to be used for suture and/or soft tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in, but not limited to, the following procedures: · Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. · Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair. · Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis. • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. · Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
    Device Description
    The Aevumed PHANTOM ™ Anchor with HS Fiber ™ suture is a threaded suture anchor manufactured from polyetheretherketone (PEEK) material preloaded on a disposable driver assembly intended for fixation of soft tissue to bone. The Aevumed PHANTOM ™ Anchor with HS Fiber ™ are pre-loaded with or without needles. The Aevumed PHANTOM ™ Suture Anchor are available in diameter sizes: 5.5mm and 6.5mm. They are offered sterile and are for single use only.
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