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510(k) Data Aggregation

    K Number
    K121354
    Device Name
    MICRO/MINI N-PK(F) BONE ANCHOR
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Date Cleared
    2012-11-09

    (189 days)

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

    ANULEX TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle - . Hallux valgus repairs - Medial or lateral instability repairs/reconstructions . - Achilles tendon repairs/reconstructions - . Midfoot reconstructions - Metatarsa} ligament/tendon repairs/reconstructions . - . Bunionectomy
    Device Description
    The Micro/Mini N-PK(F) Bone Anchor consists of an adjustable loop of non-absorbable suture (Sizes 2, 0 and 2-0) with one (1) or two (2) attached anchors. The bone anchor is a two part system, one part nickel-titanium (nitinol) and the second part polyetheretherketone (PEEK). The PEEK part resides within the nitinol sleeve and retains the suture. The nitinol part expands upon delivery providing resistance to pullout. The construct is provided sterile and preloaded on a disposable delivery instrument.
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    K Number
    K121356
    Device Name
    MICRO/MINI N-PK(H) BONE ANCHOR
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Date Cleared
    2012-11-09

    (189 days)

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

    ANULEX TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Elbow, Hand and Wrist - Biceps tendon reattachment - Ulnar or lateral collateral ligament reconstruction . - ◆ Scapholunate ligament reconstruction - . Lateral epicondylitis repair
    Device Description
    The Micro/Mini N-PK(H) Bone Anchor consists of an adjustable loop of non-absorbable suture (Sizes 2, 0 and 2- 0) with one (1) or two (2) attached anchors. The bone anchor is a two part system, one part nickel-titanium (nitinol) and the second part polyetheretherketone (PEEK). The PEEK part resides within the nitinol sleeve and retains the suture. The nitinol part expands upon delivery providing resistance to pullout. The construct is provided sterile and preloaded on a disposable delivery instrument.
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    K Number
    K113805
    Device Name
    FIXATE TISSUE BAND
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Date Cleared
    2012-02-23

    (62 days)

    Product Code
    GZB, GAT
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANULEX TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The fiXate Tissue Band is intended to be an accessory to the leads/catheter component of Spinal Cord Stimulator/Pain Pump systems functioning to secure the lead to the fascia or inter- spinous/supra- spinous ligament.
    Device Description
    The fiXate Tissue Band consists of an adjustable loop of non- absorbable 2-0 suture (UHMWPE or PET (coated or uncoated) ) with two (2) attached anchors (PEEK Optima LT1 or PET). The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub- layer of tissue.
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    K Number
    K113400
    Device Name
    FIXATE TISSUE BAND
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Date Cleared
    2011-12-16

    (29 days)

    Product Code
    GZB, GAT
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANULEX TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.
    Device Description
    The fiXate Tissue Band consists of an adjustable loop of non-absorbable 2-0 suture with two (2) attached anchors. The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub-layer of tissue.
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    K Number
    K112849
    Device Name
    FIXATE TISSUE BAND
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Date Cleared
    2011-10-27

    (28 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANULEX TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.
    Device Description
    The fiXate Tissue Band consists of an adjustable loop of non-absorbable 2-0 suture with two (2) attached anchors. The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub-layer of tissue.
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    K Number
    K111462
    Device Name
    FIXATE TISSUE BAND
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Date Cleared
    2011-09-08

    (105 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANULEX TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.
    Device Description
    The fiXate Tissue Band consists of an adjustable loop of non-absorbable 2-0 suture with two (2) attached anchors. The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub-layer of tissue.
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    K Number
    K100572
    Device Name
    VERSACLOSE, MODEL VC-200-01
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Date Cleared
    2010-03-17

    (16 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANULEX TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Versaclose is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
    Device Description
    The Versaclose implant is comprised of one (1) Peek Optima (LT1) Toggle-anchor, connected to an adjustable 2-0 braided suture loop, made of ultra high molecular weight polyethylene (UHMWPE) force fiber suture. The suture component conforms to USP requirements. The construct is provided sterile and preloaded on a disposable delivery instrument.
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    K Number
    K091432
    Device Name
    XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Date Cleared
    2009-06-12

    (29 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANULEX TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Xclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
    Device Description
    The modified Xclose™ Tissue Repair System consists of two (2) non-absorbable braided surgical 3-0 suture (Ultra High Molecular Weight Polyethylene, UHMWPE) and T-anchor (polyethylene terephthalate, PET) assemblies, connected together with a loop of green 2-0 suture (PET). The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture/anchor assemblies together, thereby re-approximating the tissue. The suture components conform to USP requirements The construct is provided sterile and preloaded on a disposable delivery instrument.
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    K Number
    K082729
    Device Name
    RIMCLOSE BONE ANCHOR
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Date Cleared
    2008-12-19

    (92 days)

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

    ANULEX TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rimclose Bone Anchor is intended for fixation of suture to bone. This product is intended for the following indications: Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
    Device Description
    The Rimclose Bone Anchor consists of one (1) bone anchor assembly, pre-loaded on a disposable delivery tool. The Bone Anchor is packaged with a disposable Bone Awl to facilitate placement of the device. The device is provided in one size only. The bone anchor assembly is comprised of one (1) titanium (Ti-6Al-4V ELI) toggle-anchor, connected to an adjustable polyethylene terephthalate (PET) 2-0 braided suture loop, via an intermittent length of size 0 ultra high molecular weight polyethylene (UHMWPE) Force Fiber suture. The device's titanium component conforms to ASTM F-136. The device's polyethylene terephthalate (PET) and ultra high molecular weight polyethylene (UHMWPE) suture components conform to USP requirements. The constructs are provided sterile and preloaded on disposable delivery instruments.
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    K Number
    K062307
    Device Name
    XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Date Cleared
    2006-09-01

    (24 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANULEX TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Xclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
    Device Description
    The Xclose™ Tissue Repair System consists of two (2) non- absorbable braided surgical 3-0 suture and T-anchor assemblies, connected together with a loop of green 2-0 suture. The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture assemblies together, thereby re-approximating the tissue. The device construct is composed of polyethylene terephthalate (PET) and conforms to USP requirements. The construct is provided sterile and preloaded on a disposable delivery instrument.
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