FDA 510(k)

Tigon Medical Fractures, Instability, and Reconstruction (FIRE)

Numéro K : K240175 · 2024-10-29

Date de décision2024-10-29

Code produitHWC

Comité consultatifPolitique : medical-regulatory-v1 OU

DécisionSubstantially Equivalent

Résumé du dispositif

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is the device name listed in this FDA 510(k) record. The listed applicant is Tigon Medical. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K240175. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Tigon Medical Fractures, Instability, and Reconstruction (FIRE)?

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Tigon Medical. The 510(k) number is K240175.

When did Tigon Medical Fractures, Instability, and Reconstruction (FIRE) receive FDA 510(k) clearance?

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) received FDA 510(k) clearance on 2024-10-29, under 510(k) number K240175.

Who is the listed applicant for Tigon Medical Fractures, Instability, and Reconstruction (FIRE)?

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

What is the FDA product code for Tigon Medical Fractures, Instability, and Reconstruction (FIRE)?

The FDA product code for Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is HWC. This falls under the Cardiovascular category.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549Étude pilote de phase 1 sur la sécurité du FLASHNOT_YET_RECRUITING NCT06562205Systèmes PAP Études Cliniques Externes (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Système d'évaluation du cathéter Uro-Cam assisté par intelligence artificielle pour le diagnostic du cancer de la vessieNOT_YET_RECRUITING

Autres dossiers indiquant Tigon Medical en tant que demandeur

K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line K252596Tigon Medical Knotless and Dual Javelin All-Suture Anchors K242529Tigon Medical All-Suture Anchors (ASA)K220464Tigon Medical Gryphon Anchor Line K211049Tigon Medical Button System K182507Tigon Medical Tissue Anchors

Voir tous les 7 dispositifs →

Dispositifs connexes (Code : HWC)

K262975Système Arthrex BeamingArthrex, Inc.K260995Système de Fixation DynaNail Helix®MedShape, Inc.K254280Visserie F.A.S.T.Steps Ortho K261057ActivaScrew™ Visé COMBioretec, Ltd.K260106Système de Compression Active OsteoCoil™ GTFlower Orthopedics Corporation DBA Conventus Flower Orthoped K262344Visserie de Compression LargeTriMed, Inc.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.