FDA 510(k)

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants

K-Nummer: K250713 · 2025-12-01

Entscheidungsdatum2025-12-01

ProduktcodeKWT

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2025-12-01 under 510(k) number K250713. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants?

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants is a medical device that received FDA 510(k) clearance on 2025-12-01. The listed applicant is Exactech, Inc.. The 510(k) number is K250713.

When did Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants receive FDA 510(k) clearance?

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants received FDA 510(k) clearance on 2025-12-01, under 510(k) number K250713.

Who is the listed applicant for Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants?

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

What is the FDA product code for Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants?

The FDA product code for Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants is KWT.

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 Exactech, Inc. als Antragsteller

K260583Equinoxe® Shoulder System K243448Equinoxe® Shoulder System K243275Equinoxe® Scapula Fracture System K243839Alteon® HA Hüftpfannen K240393Exactech® TRULIANT® Knee System K233482Equinoxe® Central Screw Baseplate System

Alle 40 Geräte anzeigen →

Verwandte Geräte (Code: KWT)

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO SchulterersatzsystemImplantcast GmbH K241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO SchulterersatzsystemImplantcast GmbH K223631Comprehensive Segmental Revision System(SRS)Biomet Orthopedics

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.