FDA 510(k)

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional

Numéro K : K190963 · 2019-07-23

Date de décision2019-07-23

Code produitHRS

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-07-23 under 510(k) number K190963. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional?

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional is a medical device that received FDA 510(k) clearance on 2019-07-23. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K190963.

When did DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional receive FDA 510(k) clearance?

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional received FDA 510(k) clearance on 2019-07-23, under 510(k) number K190963.

Who is the listed applicant for DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional?

The FDA product code for DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional is HRS.

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

Autres dossiers indiquant Synthes (USA) Products, LLC en tant que demandeur

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System K212943SyntheCel Dura Repair K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)K210408DePuy Synthes Variable Angle Locking Patella Plating System K210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

Voir tous les 30 dispositifs →

Dispositifs connexes (Code : HRS)

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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.