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510(k) Data Aggregation
K Number
K062391Device Name
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00
Manufacturer
TRIAGE MEDICAL, INC.
Date Cleared
2006-09-14
(29 days)
Product Code
MRW
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TRIAGE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 4.5mm Facet Compression Device, which is included in the Disposable Posterior Lumbar Stabilization Procedure Kit, 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 Facet Compression Device 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 Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm Facet Compression Device.
Device Description
The 4.5mm Facet Compression Device(s) contained in the Disposable Posterior Lumbar Stabilization Procedure Kit is a double-helix screw with a compression-locking collar and self-retaining washer. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. Disposable surgical instruments for use in implanting the device are also included in the kit. The kit is provided "STERILE"; sterilization is by gamma radiation. The re-usable Compression Tool is provided separately in a "NONSTERILE" condition; sterilization is by moist heat (steam autoclaye) and is performed on-site.
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K Number
K052043Device Name
3.8MM CS FACET COMPRESSION DEVICE
Manufacturer
TRIAGE MEDICAL, INC.
Date Cleared
2005-10-17
(81 days)
Product Code
MRW
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TRIAGE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3.8mm CS Facet Compression Device is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis and failed previous fusion. The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1.
Device Description
The 3.8mm CS Facet Compression Device is a double-helix screw with a compressionlocking collar, and is provided with or without a self-retaining washer. It is available in various length ranges fabricated from either Titanium 6Al-4V, which meets the requirements of ASTM F-136 or stainless steel, which meets the requirements of ASTM F-138.
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K Number
K051949Device Name
4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040
Manufacturer
TRIAGE MEDICAL, INC.
Date Cleared
2005-08-05
(21 days)
Product Code
MRW
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TRIAGE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or 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 LS Facet Compression Device with Polymer Washer 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 LS Facet Compression Device with Polymer Washer is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
Device Description
The 4.5mm LS Facet Compression Device is a double-helix screw with a compressionlocking collar. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. The 4.5mm LS Facet Compression Device with Polymer Washer is intended for single use only.
Devices are provided "STERILE" and are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.
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K Number
K042244Device Name
BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
Manufacturer
TRIAGE MEDICAL, INC.
Date Cleared
2004-09-16
(28 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
TRIAGE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BONE-LOK® MVP Cortical-Cancellous Compression Device is indicated for use in the general management of fractures and reconstructive surgery.
Device Description
The BONE-LOK® MVP Cortical-Cancellous Compression Device is a double-helix screw with a compression-locking collar. It is available as 3.5mm or 4.5mm diameter device with a compression looking ochan 1978 - The BONE-LOK® MVP Cortical-Cancellous Compression Device is intended for single use only. Devices provided "STERILE" are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.
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