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FDA 510(k)

AOS ES Retrograde Femoral Nail

K-Number: K191598 · 2019-07-18

ApplicantAdvanced Orthopaedic Solutions, Inc.
Decision Date2019-07-18
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Advanced Orthopaedic Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202489AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating SystemK202099AOS Galileo™ Trochanteric Nail SystemK182466AOS Calcaneal Plating SystemK160409AOS Anterolateral Proximal Humeral Plate

Related Devices (Code: HSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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