FDA 510(k)

Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner

K-Nummer: K230315 · 2023-03-06

Entscheidungsdatum2023-03-06

ProduktcodeQHE

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Materialise Shoulder System™ 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 2023-03-06 under 510(k) number K230315. 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 System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner?

Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner is a medical device that received FDA 510(k) clearance on 2023-03-06. The listed applicant is Materialise NV. The 510(k) number is K230315.

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

Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner received FDA 510(k) clearance on 2023-03-06, under 510(k) number K230315.

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

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

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

Alle 34 Geräte anzeigen →

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 →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.