METICULY Patient-specific titanium mesh implant

• K Number: K252958
• Device Name: METICULY Patient-specific titanium mesh implant
• Manufacturer: Meticuly Co., Ltd.
• Date Cleared: 2026-01-14 ( 120 days)
• Product Code: GXN
• Regulation Number: 882.5330
• Type: Traditional
• Panel: Neurology
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).