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K Number
K022185
Device Name
UNIVERSAL CMF SYSTEM
Manufacturer
STRYKER INSTRUMENTS
Date Cleared
2002-12-17

(167 days)

Product Code
JEY
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K014263,K002619,K862482,K854886,K953806,K993862,K862532
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Stryker® Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.

Device Description

The Stryker Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system.

AI/ML Overview

This 510(k) summary describes a Cranio-maxillofacial (CMF) plate and screw system. The document does not contain information about the acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.

The 510(k) submission states that the Universal CMF System is "substantially equivalent" to several legally marketed predicate devices. This type of submission relies on demonstrating similarity to existing devices rather than new performance studies with specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set) is not available in the provided text.

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.