FDA 510(k)

DePuy Synthes Variable Angle Locking Patella Plating System

N.º K: K210408 · 2021-04-08

Fecha de decisión2021-04-08

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

DePuy Synthes Variable Angle Locking Patella Plating System 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 2021-04-08 under 510(k) number K210408. 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 Variable Angle Locking Patella Plating System?

DePuy Synthes Variable Angle Locking Patella Plating System is a medical device that received FDA 510(k) clearance on 2021-04-08. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K210408.

When did DePuy Synthes Variable Angle Locking Patella Plating System receive FDA 510(k) clearance?

DePuy Synthes Variable Angle Locking Patella Plating System received FDA 510(k) clearance on 2021-04-08, under 510(k) number K210408.

Who is the listed applicant for DePuy Synthes Variable Angle Locking Patella Plating System?

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 Variable Angle Locking Patella Plating System?

The FDA product code for DePuy Synthes Variable Angle Locking Patella Plating System is HRS.

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Otros registros que enlistan a Synthes (USA) Products, LLC como solicitante

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System K212943SyntheCel Dura Repair K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)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 K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

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Fuente oficial

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