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510(k) Data Aggregation
K Number
K110047Device Name
VERTICOR K-WIRE SYSTEM
Manufacturer
VERTICOR, LTD
Date Cleared
2011-02-28
(53 days)
Product Code
HTY, JDW
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
VERTICOR, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Verticor K-Wire System is intended for use in fixation of bone fractures, fusion of joints or bone reconstruction, for osteotomies in the presence of adequate immobilization and as guide pins for insertion of other implants.
Device Description
K-wires are sharpened or blunt, smooth stainless steel pins. They come in different sizes and are used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction. To ensure the multi-use of these devices, many different models are available. Threaded K-wires are available for situations where backing out of the pin is undesirable.
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K Number
K103137Device Name
VENUS ANTERIOR CERVICAL PLATE
Manufacturer
VERTICOR, LTD
Date Cleared
2011-02-10
(108 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
VERTICOR, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VENUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors,
- deformity (defined as kyphosis, lordosis, or scoliosis),
- pseudarthrosis,
- failed previous fusion,
- spinal stenosis.
WARNING: The VENUS Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Device Description
The VENUS Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with selftapping and self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths, addressing multiple levels of fixation. Bone screws are available for fixed angle or variable angle implantation in a variety of lengths and diameters. Each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism.
Materials:
The plates and screws are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136. The screw retainer clip is fabricated from medical grand nitanol SE 508.
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K Number
K091426Device Name
CERVICORE CORPECTOMY CAGE
Manufacturer
VERTICOR, LTD
Date Cleared
2009-12-23
(224 days)
Product Code
MQP
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
VERTICOR, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Samson Corpectomy System is a vertebral body replacement system indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Samson Corpectomy System is intended for use with supplemental fixation and is to be used with autograft and/or allograft.
Device Description
Not Found
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