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510(k) Data Aggregation
K Number
K190291Device Name
Addivation Medical Cervical Interbody System
Manufacturer
Date Cleared
2019-07-30
(169 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Addivation Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Addivation Medical Cervical Interbody System is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.
DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.
The Addivation Medical Cervical Interbody System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft, and is to be implanted via an open, anterior approach.
The Addivation Medical Cervical Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
Device Description
The Addivation Medical Cervical Interbody System is a series of hollow, titanium interbody fusion cages intended for use in the cervical spine. The cage consists of an open window for bone graft containment and has serrations on the superior and inferior surfaces of the cage for fixation. The cage is offered in a variety of footprints, heights, and lordotic angles to adapt to varying patient anatomies. The Addivation Medical Cervical Interbody System implants are simultaneously built using Electron Beam Melting (EBM) method of additive manufacturing. Addivation Medical Cervical Interbody System Implants are provided sterile.
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