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510(k) Data Aggregation

    K Number
    K043351
    Device Name
    4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N
    Manufacturer
    TRIAGE MEDICAL INC
    Date Cleared
    2005-02-18

    (74 days)

    Product Code
    MRW
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRIAGE MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 4.5mm BONE-LOK® Facet Screw is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion. The intended use of the 4.5mm BONE-LOK® Facet Screw is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm BONE-LOK® Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to Sl.
    Device Description
    The 4.5mm BONE-LOK® Facet Screw is a double-helix screw with a compressionlocking collar and a self-retaining washer. It is available as a 30-40mm range device fabricated from either stainless steel, which meets the requirements of ASTM F-138, or Titanium 6Al-4V, which meets the requirements of ASTM F-136.
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    K Number
    K040250
    Device Name
    BONE-LOK HP WASHER
    Manufacturer
    TRIAGE MEDICAL INC
    Date Cleared
    2004-03-23

    (50 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRIAGE MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BONE-LOK™ HP Washer is an accessory intended for use with the BONE-LOK™ HP Cannulated Helical Compression Anchor System, in the general management of fractures and reconstructive surgery.
    Device Description
    The BONE-LOK™ HP Washer is intended for use with BONE-LOK™ HP Cannulated Helical Compression Anchor System in the general management of fractures and reconstructive surgery. The washer provides a bearing surface for the screw head against the bone and also prohibits migration of the screw head into the cortex. The BONE-LOK™ HP Washer is fabricated from Titanium 6AI-4V ELI, which meets the requirements of ASTM-136. The BONE-LOK™ HP Washer is provided "NON-STERILE" and will require subsequent sterilization on site. The BONE-LOK™ HP Washer will be supplied as a part of the BONE-LOK™ HP Instrument Kit or as individual units packaged in a labeled poly bag. The Instrument Kit is distributed in a custom autoclavable compartmentalized tray with a locking lid. Both the BONE-LOK™ HP Washer and the Instrument Kit may be sterilized by moist heat. The sterilization validation method is in conformance with international standards (EN 554 and ISO/ANSI/AAMI 11134). Sterilization instructions are included in the Instructions for Use.
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    K Number
    K014304
    Device Name
    BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
    Manufacturer
    TRIAGE MEDICAL INC
    Date Cleared
    2002-03-27

    (86 days)

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

    TRIAGE MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is indicated for use in the general management of fractures and This device is indication for ass litht bearing applications with proper postoperative immobililzation.
    Device Description
    Not Found
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    K Number
    K014243
    Device Name
    BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050
    Manufacturer
    TRIAGE MEDICAL INC
    Date Cleared
    2002-03-26

    (90 days)

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

    TRIAGE MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is indicated for use in the general management of fractures and reconstructive surgery in non-weight bearing applications with proper postoperative immobililzation.
    Device Description
    Bone-Lok™ Bioabsorbable Compression Anchor with Titanium Fixture and Bone-Lok™ Bioabsorbable Compression Anchor
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    K Number
    K012817
    Device Name
    HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
    Manufacturer
    TRIAGE MEDICAL INC
    Date Cleared
    2001-11-20

    (90 days)

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

    TRIAGE MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used in general management of fractures and reconstructive surgery.
    Device Description
    Not Found
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    K Number
    K012818
    Device Name
    HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
    Manufacturer
    TRIAGE MEDICAL INC
    Date Cleared
    2001-11-20

    (90 days)

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

    TRIAGE MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are used for the correction of hallux valgus (bunion) and repair of metatarsal, metacarpal and phalangeal fractures.
    Device Description
    Helical Compression Anchor, Cannulated, Single and Double Helix
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    K Number
    K012280
    Device Name
    TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
    Manufacturer
    TRIAGE MEDICAL INC
    Date Cleared
    2001-08-17

    (29 days)

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

    TRIAGE MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used for the correction of hallux valgus (bunion) and repair of metatarsal, metacarpal and phalangeal fractures.
    Device Description
    Titanium Compression Anchor System
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