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510(k) Data Aggregation
K Number
K162154Device Name
Pantheon Medical Balanced Plating System
Manufacturer
Date Cleared
2017-04-24
(265 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
PANTHEON MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pantheon Medical Balanced Plating System is intended for fixation of fractures, revision procedures, joint fusion, non-unions, and reconstruction of orthopedic small bone extremities. This system is not intended for spinal use.
Device Description
The Pantheon Medical Balanced Plating System consists of multiple plate families of various anatomical sizes and shapes, 2.7mm and 3.5mm locking and non-locking screws which mate into the plates, as well as a 4.0mm compression screw that is utilized with the Lapidus plate. Various instruments are also included to assist in implanting the system.
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