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510(k) Data Aggregation

K Number

Device Name

SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828

Manufacturer

BIONX IMPLANTS, LTD.

Date Cleared

2000-03-23

(28 days)

Product Code

Regulation Number

Type

Panel

Orthopedic (OR)

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N/A

Why did this record match?

Device Name :

SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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