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510(k) Data Aggregation
K Number
K182477Device Name
Cervical Spacer
Manufacturer
Additive Implants, LLC
Date Cleared
2019-01-28
(140 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Additive Implants, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Cervical Spacer is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Cervical Spacer is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
Device Description
The Cervical Spacer is an additively manufactured interbody device. These cervical implants have basic keystone shape and an open architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The Cervical Spacers are provided sterile only.
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