FDA 510(k)

GPC Intraheal Intramedullary Nailing System

N.º K: K203811 · 2022-02-10

Fecha de decisión2022-02-10

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

GPC Intraheal Intramedullary Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Gpc Medical Limited. It received FDA 510(k) clearance on 2022-02-10 under 510(k) number K203811. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the GPC Intraheal Intramedullary Nailing System?

GPC Intraheal Intramedullary Nailing System is a medical device that received FDA 510(k) clearance on 2022-02-10. The listed applicant is Gpc Medical Limited. The 510(k) number is K203811.

When did GPC Intraheal Intramedullary Nailing System receive FDA 510(k) clearance?

GPC Intraheal Intramedullary Nailing System received FDA 510(k) clearance on 2022-02-10, under 510(k) number K203811.

Who is the listed applicant for GPC Intraheal Intramedullary Nailing System?

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

What is the FDA product code for GPC Intraheal Intramedullary Nailing System?

The FDA product code for GPC Intraheal Intramedullary Nailing System is HSB.

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Otros registros que enlistan a Gpc Medical Limited como solicitante

K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System

Dispositivos relacionados (Código: HSB)

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbH K253080Sistema de Clavo Femoral AND Medical (PFNA01); Sistema de Clavo Femoral AND Medical (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

Fuente oficial

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