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K Number
K050535
Device Name
STRYKER MMF SCREW
Manufacturer
STRYKER INSTRUMENTS
Date Cleared
2005-03-17

(15 days)

Product Code
DZL
Regulation Number
872.4880
Type
Traditional
Panel
DE
Reference & Predicate Devices
K963030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Stryker® MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth.

The document is a 510(k) summary for a medical device (Stryker® MMF Screw) establishing substantial equivalence to a predicate device. It defines the intended use and regulatory classification but does not include any performance study details or acceptance criteria.

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.