FDA 510(k)

Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner

K-Nummer: K220452 · 2022-08-17

Entscheidungsdatum2022-08-17

ProduktcodeQHE

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2022-08-17 under 510(k) number K220452. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner?

Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner is a medical device that received FDA 510(k) clearance on 2022-08-17. The listed applicant is Materialise NV. The 510(k) number is K220452.

When did Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner receive FDA 510(k) clearance?

Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner received FDA 510(k) clearance on 2022-08-17, under 510(k) number K220452.

Who is the listed applicant for Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner?

The FDA 510(k) record lists Materialise NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner?

The FDA product code for Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner is QHE.

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Weitere Einträge mit Materialise NV als Antragsteller

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K251964Mimics Thoracic Planner K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models K253793Materialise TKA Guide System K251554Materialise TKA Guide System K243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

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Verwandte Geräte (Code: QHE)

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.K243509Archer PSI System3D-Side K241470CORE Shoulder SystemLinkBio Corp.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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