AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR by AXYA MEDICAL, INC. | FDA 510(k) Summary

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K Number

Validate with FDA (Live)

Device Name

AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR

Manufacturer

AXYA MEDICAL, INC.

Date Cleared

2001-03-21

(89 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K022207,K083268

Intended Use

Device Description

AI/ML Overview

Summary

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Regulation Number and Section

N/A