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510(k) Data Aggregation

K Number

Device Name

Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories

Manufacturer

Stryker Leibinger GmbH & Co. KG

Date Cleared

2024-07-25

(90 days)

Product Code

OLO,ERL,HBE,HWE

Regulation Number

Type

Panel

Orthopedic (OR)

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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