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K Number
K031028
Device Name
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
Manufacturer
BIOPLATE, INC.
Date Cleared
2003-04-28

(27 days)

Product Code
JEY
Regulation Number
872.4760
Type
Special
Panel
DE
Reference & Predicate Devices
K022890,K021684,K972463,K943071
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation. including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Device Description

The modified screw designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and may be used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.

AI/ML Overview

The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for a medical device (Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery) which asserts "substantial equivalence" to previously marketed predicate devices.

The document states: "All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy." This indicates that the device's characteristics were compared to existing, approved devices, and no new studies demonstrating performance against specific acceptance criteria were necessary for this 510(k) clearance process.

Therefore, I cannot provide the requested information in the table or address points 2 through 9, as they pertain to a type of study that was not described or performed for this specific submission based on 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.