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510(k) Data Aggregation
K Number
K193211Device Name
Nano FortiFix® System
Manufacturer
Nanovis Spine LLC
Date Cleared
2020-03-20
(120 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Nanovis Spine LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nano FortiFix® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the non-cervical spine for the following indications: DDD (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion.
Device Description
Nano FortiFix® is a posterior pedicle screw system consisting of rods, polyaxial pedicle screws, connectors and fasteners in a variety of sizes to accommodate differing anatomic requirements. The Nano FortiFix® pedicle screw shaft is available with or without a nanosurface. The Nano FortiFix® nano pedicle screw has a micro- and nano-roughened surface that demonstrates the requirements for nanotechnology. The surface of the nano screw threads has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. These threads are electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface.
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K Number
K162250Device Name
FortiBridge Anterior Cervical Plate System
Manufacturer
NANOVIS SPINE LLC
Date Cleared
2016-10-26
(77 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
NANOVIS SPINE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
Device Description
The FortiBridge™ System consists of implants and instruments for implantation. It is an anterior cervical plate and screw system which includes fixed and variable screws having standard, self-drilling or self-tapping tips, and one- through four-level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient. The devices are sold sterile.
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K Number
K143706Device Name
FortiBridge Anterior Cervical Plate System
Manufacturer
Nanovis Spine LLC
Date Cleared
2015-04-10
(102 days)
Product Code
KWQ, KWO
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Nanovis Spine LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis or scoliosis), pseudarthrosis or failed previous fusion.
Device Description
The FortiBridge™ System consists of implants and instruments for implantation. It is an anterior cervical plate and screw system which includes fixed and variable screws having standard, self-drilling or self-tapping tips, and one- through four-level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.
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