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510(k) Data Aggregation
K Number
K152239Device Name
Zero-P Natural Plate System
Manufacturer
Date Cleared
2015-12-02
(114 days)
Product Code
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Synthes (USA), LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The plate and four screw system has been designed for use with structural allograft to provide stabilization as an adjunct to cervical fusion. Indications for use of this plate system include degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis or scoliosis), tumor, pseudarthosis or failed previous fusion. The plate is intended for one level in the cervical spine, from C2 to T1.
Device Description
The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The Zero-P Natural Plate and four screw system has been designed to provide stabilization as an adjunct to cervical fusion. The Zero-P Natural Plate is secured to the spine through unicortical fixation with bone screws. The plate is positioned flush with the adjacent vertebral bodies. Four bone screws attach to the plate for fixation through the adjacent vertebral bodies; two screws are directed into the superior and inferior vertebrae through the endplates.
The Zero-P Natural Plate has been designed for use with a Musculoskeletal Transplant Foundation (MTF) allograft spacer. Size pairings of the Zero-P Natural Plate and the allograft spacer are identified in the labeling to ensure a proper fit and height relationship of the allograft spacer to the Zero-P Natural Plate.
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