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510(k) Data Aggregation

K Number

Device Name

CurvaFix Low Profile System

Manufacturer

Date Cleared

2025-08-29

(60 days)

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Regulation Number

Type

Panel

Orthopedic (OR)

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Device Name :

CurvaFix Low Profile System

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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