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510(k) Data Aggregation
K Number
K032815Device Name
PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM
Manufacturer
PRECISION SURGERY LIMITED
Date Cleared
2004-02-12
(156 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
PRECISION SURGERY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Precision Surgery Limited Variable and Fixed 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, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
Device Description
The Precision Surgery Limited Variable and Fixed Cervical Plate System includes plates and screw components. There are three types of plates available, two variable and one fixed. Primary and rescue screws are available.
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