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510(k) Data Aggregation
K Number
K062371Device Name
PREVIEW ANTERIOR CERVICAL PLATE SYSTEM
Manufacturer
ALPHASPINE, INC.
Date Cleared
2006-12-04
(112 days)
Product Code
KWQ, KWO
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
ALPHASPINE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PreView™ Anterior Ccrvical Plate System is intended for the treatment of the cervical spine in skeletally mature patients.receiving fusion-by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The PreView™ Anterior Cervical Plate System is intended for use under the following indications: )
· Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
- · Trauma (i.e., fracture or dislocation)
· Spinal stenosis
- · Deformitics or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
- Pseudoarthrosis
- · Failed previous fusion
Device Description
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