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510(k) Data Aggregation
K Number
K222987Device Name
Akunah REFLECT
Manufacturer
Akunah PTY LTD
Date Cleared
2023-05-10
(224 days)
Product Code
LLZ, QIH
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Akunah PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Akunah Reflect Planning Software is intended to be used as a pre-surgical planner for shoulder arthroplasty, fracture, deformity correction and stabilisation procedures. The software is used to assist in the positioning of shoulder components. Akunah Reflect Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. The software leads to the generation of a planning report. The software is to be used for adult patients only and should not be used for diagnostic purposes. Akunah Reflect should be used in conjunction with expert clinical judgement.
Device Description
Akunah REFLECT Software is intended to be used as a pre-surgical planner for shoulder arthroplasty, fracture, deformity correction and stabilisation procedures. The user interface software is connected to an online management system (OMS), and is intended to be used by orthopaedic surgeons as a preoperative planning software for shoulder surgery. The software is intended to allow surgeons to:
- Visualize, measure, reconstruct, and annotate anatomic data,
- Select and position shoulder implant devices,
- . Output pre-surgical planning reports
The software is to be used for adult patients only and should not be used for diagnostic purpose.
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