FDA 510(k)

Femoral Trochanteric Nail System – Neonail

Numéro K : K221021 · 2022-12-06

DemandeurNeoortho Produtos Ortopédicos S/A

Date de décision2022-12-06

Code produitHSB

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Femoral Trochanteric Nail System – Neonail is the device name listed in this FDA 510(k) record. The listed applicant is Neoortho Produtos Ortopédicos S/A. It received FDA 510(k) clearance on 2022-12-06 under 510(k) number K221021. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Femoral Trochanteric Nail System – Neonail?

Femoral Trochanteric Nail System – Neonail is a medical device that received FDA 510(k) clearance on 2022-12-06. The listed applicant is Neoortho Produtos Ortopédicos S/A. The 510(k) number is K221021.

When did Femoral Trochanteric Nail System – Neonail receive FDA 510(k) clearance?

Femoral Trochanteric Nail System – Neonail received FDA 510(k) clearance on 2022-12-06, under 510(k) number K221021.

Who is the listed applicant for Femoral Trochanteric Nail System – Neonail?

The FDA 510(k) record lists Neoortho Produtos Ortopédicos S/A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Femoral Trochanteric Nail System – Neonail?

The FDA product code for Femoral Trochanteric Nail System – Neonail is HSB.

Essais cliniques associés

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Dispositifs connexes (Code : HSB)

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbH K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (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.

Source officielle

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