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510(k) Data Aggregation
K Number
K091936Device Name
BLADE ANTERIOR CERVICAL PLATE SYSTEM
Manufacturer
NEXXT MEDICAL INC
Date Cleared
2010-01-19
(203 days)
Product Code
KWQ, KWO
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
NEXXT MEDICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blade™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Device Description
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