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510(k) Data Aggregation
K Number
K181140Device Name
Axis Chena Cervical PEEK Spacer System
Manufacturer
Date Cleared
2018-11-16
(200 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Axis Orthopaedics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Chena Cervical Peek Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Chena Cervical Peek Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The Chena Cervical Peek Spacer is intended to be used with supplemental fixation.
Device Description
The Axis Chena Cervical PEEK Spacer System consists of a variety of footprints and heights of PEEK cervical interbody spacer implants to assist in interbody fusion.
The Axis Chena Cervical PEEK Spacer System implant components are fabricated from medical implant grade Polyetheretherketone and tantalum described by such standards as ASTM F2026-17 and ASTM F560-17. Axis Orthopaedics Corporation expressly warrants that these devices are fabricated from one of the foregoing material specifications.
Do not use any of the Axis Chena Cervical PEEK Spacer System implant components with components from any other system or manufacturer. As with all orthopaedic and neurosurgical implants, none of the Axis Chena Cervical PEEK Spacer System components should ever be reused under any circumstances.
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K Number
K180301Device Name
AXIS 5.5 Lumbar Pedicle Screw System
Manufacturer
Date Cleared
2018-04-10
(67 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Axis Orthopaedics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AXIS 5.5 LUMBAR PEDICLE SCREW SYSTEM is intended for posterior, non-cervical fixation of skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
Device Description
The AXIS 5.5 LUMBAR PEDICLE SCEW System consists of a variety of shapes and sizes of rods, screws, Crosslink plates, which can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case.
The AXIS 5.5 LUMBAR PEDICLE SCEW System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2.
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K Number
K173867Device Name
Axis Anterior Cervical Plate System
Manufacturer
Date Cleared
2018-04-05
(106 days)
Product Code
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Axis Orthopaedics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Axis 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 from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudoarthrosis (defined as failed previous fusion).
Device Description
Axis Anterior Cervical Plate System is a plate and screw system composed of medical grade titanium Ti-Alloy (Ti-6Al-4V ELI) components. The titanium plates are available in a variety of lengths, addressing multiple levels of fixation. The plates contain an integrated locking mechanism which interfaces with fixed and variable angled screws, of various diameters and lengths, to accommodate anatomical variation when securing the plate-screw construct to the anterior cervical vertebral bodies. The system is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal cervical spine lordosis, and at the same time eliminate the need for additional plate contouring, Axis Anterior Cervical Plates come with a prelordosed curve. Various instruments are available to facilitate the implantation of the device.
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