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510(k) Data Aggregation
K Number
K042713Device Name
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
Manufacturer
SPINE NEXT AMERICA CORPORATION
Date Cleared
2004-12-29
(90 days)
Product Code
MQP
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
SPINE NEXT AMERICA CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FIDJI type 5 is a vertebral body replacement device that 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 turnor or trauma (i.e., fracture). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. This device is intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System. Additionally, FIDJI type 5 is intended to be used in a paired configuration.
Device Description
The Spine Next FIDJI Vetebral Body Replacement Type 5 devices are hollow blocks that are machined from extruded Polyetheretherketone (PEEK); the blocks are tapered to aid in maintaining lordosis of the spine following implantation. The devices have angled teeth on the cephalad and caudal surfaces. The devices include tantalum inserts that serve as a location and orientation markers for radiographs.
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K Number
K042714Device Name
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4
Manufacturer
SPINE NEXT AMERICA CORPORATION
Date Cleared
2004-12-29
(96 days)
Product Code
MQP
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
SPINE NEXT AMERICA CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FIDJI types 1, 2, 3, and 4 are vertebral body replacement devices that are 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). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System.
Device Description
The FIDJI Vertebral Body Replacement Types 1, 2, 3, and 4 devices are hollow blocks that are machined from PEEK OPTIMA® (polyetheretherketone, ASTM F2026); the blocks are tapered to aid in maintaining lordosis of the spine following implantation. The devices have angled teeth on the cephalad and caudal surfaces. The devices include tantalum inserts that serve as a location and orientation markers for radiographs.
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