FDA 510(k)

AOS ES Retrograde Femoral Nail

Número K: K191598 · 2019-07-18

RequerenteAdvanced Orthopaedic Solutions, Inc.

Data da decisão2019-07-18

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AOS ES Retrograde Femoral Nail is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K191598. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AOS ES Retrograde Femoral Nail?

AOS ES Retrograde Femoral Nail is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Advanced Orthopaedic Solutions, Inc.. The 510(k) number is K191598.

When did AOS ES Retrograde Femoral Nail receive FDA 510(k) clearance?

AOS ES Retrograde Femoral Nail received FDA 510(k) clearance on 2019-07-18, under 510(k) number K191598.

Who is the listed applicant for AOS ES Retrograde Femoral Nail?

The FDA 510(k) record lists Advanced Orthopaedic Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AOS ES Retrograde Femoral Nail?

The FDA product code for AOS ES Retrograde Femoral Nail is HSB.

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Dispositivos Relacionados (Código: 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.

Fonte oficial

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