FDA 510(k)

Extremity All Suture System

Numéro K : K241695 · 2024-09-12

Date de décision2024-09-12

Code produitMBI

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Extremity All Suture System is the device name listed in this FDA 510(k) record. The listed applicant is Field Orthopaedics. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K241695. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Extremity All Suture System?

Extremity All Suture System is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Field Orthopaedics. The 510(k) number is K241695.

When did Extremity All Suture System receive FDA 510(k) clearance?

Extremity All Suture System received FDA 510(k) clearance on 2024-09-12, under 510(k) number K241695.

Who is the listed applicant for Extremity All Suture System?

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

What is the FDA product code for Extremity All Suture System?

The FDA product code for Extremity All Suture System is MBI.

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.

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

Dispositifs connexes (Code : MBI)

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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.