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510(k) Data Aggregation

    K Number
    K232014
    Device Name
    CONDUIT™ ATP Inserters
    Manufacturer
    Date Cleared
    2023-09-01

    (57 days)

    Product Code
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Enztec Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CONDUIT™ ATP Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages. The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
    Device Description
    The CONDUIT™ ATP Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using the ATP surgical approach. The inserters have been designed to interface with EIT Cellular Titanium® LLIF Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or other compatible instruments provided with the implants.
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    K Number
    K230876
    Device Name
    RI.KNEE Adjustable Tibia Cut Guide
    Manufacturer
    Date Cleared
    2023-06-27

    (89 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Enztec Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RI.KNEE Adjustable Tibia Cut Guide is intended to be used in conjunction with the CORI surgical system during total knee arthroplasty.
    Device Description
    The subject RI.KNEE Adjustable Tibia Cut Guide is a set of surgical instrument components used during total knee arthroplasty (TKA) to make the resections to the tibia by guiding a surgical saw through the saw slot. The cut guide is used with the Smith and Nephew (Blue Belt Technologies) CORI surgical system. The subject Tibia Cut Guide offers an alternative to the tibia cut guides currently available in the CORI system and provides direct attachment of the tibia tracker to reduce surgical steps for tibia tracker fixation.
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    K Number
    K223671
    Device Name
    CONDUIT LLIF Straight Inserters
    Manufacturer
    Date Cleared
    2023-01-05

    (29 days)

    Product Code
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Enztec Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CONDUIT™ LLIF Straight Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages. The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
    Device Description
    The CONDUIT™ LLIF Straight Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instruments have been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or to other instruments provided with the implants.
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    K Number
    K220449
    Device Name
    DePuy CONDUIT LLIF SQUID Inserter
    Manufacturer
    Date Cleared
    2022-06-28

    (132 days)

    Product Code
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Enztec Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DePuy CONDUIT™ LLIF SQUID Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages. EIT Cellular Titanium® LLIF Cage The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
    Device Description
    The DePuy CONDUIT™ LLIF SQUID Inserter is designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instrument has been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instrument is provided non-sterile and made from commonly used orthopedic materials. There are no changes to the implants or to other instruments provided with the implants.
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    K Number
    K212823
    Device Name
    DePuy CONDUIT LLIF Angled Inserters
    Manufacturer
    Date Cleared
    2021-11-01

    (59 days)

    Product Code
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Enztec Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DePuy CONDUIT™ LLIF Angled Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages. EIT Cellular Titanium® LLIF Cage The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nano-scale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
    Device Description
    The CONDUIT™ Lateral Angled Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instruments have been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or to other instruments provided with the implants.
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