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510(k) Data Aggregation
K Number
K180204Device Name
CranioMaxillofacial Fixation (CMF) System - CMF Visionare
Manufacturer
Visionare LLC
Date Cleared
2018-12-28
(338 days)
Product Code
JEY, DZL
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
Visionare LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.
Device Description
The subject device is a fixation system consisting of plates and screws in a variety of shapes and sizes. All plates are made of commercially pure titanium conforming to ASTM F67, and all screws are made of Ti-6Al-4V alloy conforming to ASTM F136. The subject device includes the following groups: 1.5 System Plate, 2.0 System Plates, 2.4 System Plates, Orthognathic Plates, Blocking Screws (for intermaxillary fixation, 2.0 mm diameter), and screws for use with the various plates ranging in diameter from 1.5 mm to 2.7 mm.
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