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510(k) Data Aggregation
K Number
K200549Device Name
Lucero Medical Cervical Cage System
Manufacturer
Date Cleared
2020-12-16
(288 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Lucero Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Lucero Medical Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Lucero Medical Cervical Spacer is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Lucero Medical Cervical Spacer is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine.
Device Description
The Lucero Medical Cervical Spacer is an additively manufactured interbody device. These cervical implants have basic keystone cross-sectional shape and an open structural architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The devices are provided sterile.
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K Number
K122622Device Name
ENDURAMESH
Manufacturer
Date Cleared
2012-09-19
(22 days)
Product Code
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
LUCERO MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ENDURAMESH is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device must be used with a cleared supplemental fixation system.
Device Description
The ENDURAMESH is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy, aiding in spinal fusion. The device must be used with a cleared supplemental fixation system.
The EDURAMESH vertebral body replacement system consists of a single cylindrically shaped titanium mesh cage. The hollow core of the cage allows for packing bone graft and the circular holes throughout the device promote bone fusions diameters and heights are available to accommodate variability among patients.
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K Number
K093207Device Name
ENDURAMESH, MODEL 762.XXX
Manufacturer
Date Cleared
2010-04-26
(195 days)
Product Code
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
LUCERO MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ENDURAMESH is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
Device Description
The ENDURAMESH is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy, aiding in spinal fusion. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
The ENDURAMESH vertebral body replacement system consists of a single cylindrically shaped titanium mesh cage. The hollow core of the cage allows for packing bone graft and the circular holes throughout the device promote bone fusions. Various diameters and heights are available to accommodate variability among patients.
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Ask a specific question about this device
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