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510(k) Data Aggregation
K Number
K032102Device Name
VERTELINK KOBRA SPINAL FIXATION SYSTEM
Manufacturer
Date Cleared
2003-12-12
(157 days)
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
VERTELINK CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Spinal stenosis, 3) Spondylolisthesis, 4) Spinal deformities, 5) Fractures, 6) Pseudarthrosis,7) Tumor resection, 8) Failed previous Fusion. When used as Fixation system the multiaxial screw components are also indicated for skeletally mature patients: a. Having severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebral joint, b. Who are receiving fusion using authogeneous bone graft only, c. Who are having the device fixed or attached to the lumbar or sacral spine (L.3 and below), d. Who are having the device removed after the development of solid fusion mass.
Device Description
The Vertelink KOBRA™ Spinal Fixation System is designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and pationic instabilities or deformities of the lumbar spine, spinal tumor and failed previous fusions. It can be used in either percutaneous or open surgery procedures. The system is composed of titanium pedicle screws and rods that are implanted in posterior manner either during an open surgical procedure or percutaneously using minimally invasive techniques.
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K Number
K030734Device Name
PATHWAY ACCESS SHEATH CATHETER
Manufacturer
Date Cleared
2003-09-10
(184 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
VERTELINK CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pathway™ Access Sheath Catheter is designed to facilitate the entry of interventional devices into the vessels of the cardiovascular system.
Device Description
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K Number
K030662Device Name
PATHWAY ACCESS SHEATH CATHETER
Manufacturer
Date Cleared
2003-09-03
(184 days)
Product Code
Regulation Number
876.5470Why did this record match?
Applicant Name (Manufacturer) :
VERTELINK CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The expandable sheath is designed especially for formation of large nephrostomy tracts required for percutaneous removal of renal and ureteral calculi.
Device Description
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