FDA 510(k)

DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System

N.º K: K203414 · 2020-12-16

Fecha de decisión2020-12-16

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2020-12-16 under 510(k) number K203414. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System?

DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is a medical device that received FDA 510(k) clearance on 2020-12-16. The listed applicant is DePuy Synthes. The 510(k) number is K203414.

When did DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System receive FDA 510(k) clearance?

DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System received FDA 510(k) clearance on 2020-12-16, under 510(k) number K203414.

Who is the listed applicant for DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System?

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

What is the FDA product code for DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System?

The FDA product code for DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is HRS.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a DePuy Synthes como solicitante

K233696DePuy Synthes Retrograde Femoral Nail Advanced System K233256Robotic Integration Instruments K233255CROSSNAV Navigation Enabled Instruments K233254TELIGEN System Navigation Ready Instruments K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT System

Ver todos los 18 dispositivos →

Dispositivos relacionados (Código: 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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.