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510(k) Data Aggregation
K Number
K062004Device Name
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT
Manufacturer
QUANTUM ORTHOPEDICS, INC.
Date Cleared
2006-08-15
(29 days)
Product Code
MQP
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM ORTHOPEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
Device Description
The Quantum Vertebral Body Replacement is a generally box-shaped device with various holes located throughout its geometry. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium or polyetheretherketone (PEEK).
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K Number
K061576Device Name
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM
Manufacturer
QUANTUM ORTHOPEDICS, INC.
Date Cleared
2006-07-03
(26 days)
Product Code
MQP
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM ORTHOPEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum Vertebral Body Replacement System is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
Device Description
The Quantum Vertebral Body Replacement System is composed of a flanged VBR body with screw holes and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry and teeth on its external surfaces. Screws pass through screw holes and affix to bone to help prevent implant migration. The devices are available in a multitude of sizes and are made from titanium and polyetheretherketone (PEEK).
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K Number
K052641Device Name
MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT
Manufacturer
QUANTUM ORTHOPEDICS, INC.
Date Cleared
2006-04-12
(198 days)
Product Code
MQP
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM ORTHOPEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
Device Description
The Quantum Vertebral Body Replacement is a generally box-shaped device with various holes located throughout its geometry. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium or polyetheretherketone (PEEK).
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K Number
K060491Device Name
QUANTUM ANTERIOR CERVICAL PLATE SYSTEM
Manufacturer
QUANTUM ORTHOPEDICS, INC.
Date Cleared
2006-03-13
(17 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM ORTHOPEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic only with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformaties or curvatures (lordosis, kyphosis, or scoliosis), tumors, pseudoarthrosis, and failed previous fusion.
Device Description
The Quantum Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine (C2-C7). Plates and screws are available in a variety of sizes to suit the individual pathology and unatomic condition of the patient. The device is manufactured from titanium alloy.
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K Number
K050449Device Name
QUANTUM VERTEBRAL BODY REPLACEMENT
Manufacturer
QUANTUM ORTHOPEDICS, INC.
Date Cleared
2005-07-07
(135 days)
Product Code
MQP, MOP
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM ORTHOPEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
Device Description
The Quantum Vertebral Body Replacement is a generally box-shaped device with various holes located throughout its geometry. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium or polyetheretherketone (PEEK).
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K Number
K040276Device Name
QUANTUM CEMENT RESTRICTOR
Manufacturer
QUANTUM ORTHOPEDICS
Date Cleared
2004-04-30
(85 days)
Product Code
JDK
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM ORTHOPEDICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus. This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
Device Description
The Quantum Cement Restrictor is a generally box-shaped device with various holes located throughout its geometry to hold bone cement. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium, polyetheretherketone (PEEK), or ceramic materials.
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