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FDA 510(k)

AOS Anterolateral Proximal Humeral Plate

K-Number: K171606 · 2017-06-22

ApplicantAdvanced Orthopaedic Solutions, Inc. (Aos)
Decision Date2017-06-22
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AOS Anterolateral Proximal Humeral Plate is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions, Inc. (Aos). It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K171606. The device is classified under product code KTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AOS Anterolateral Proximal Humeral Plate?

AOS Anterolateral Proximal Humeral Plate is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Advanced Orthopaedic Solutions, Inc. (Aos). The 510(k) number is K171606.

When did AOS Anterolateral Proximal Humeral Plate receive FDA 510(k) clearance?

AOS Anterolateral Proximal Humeral Plate received FDA 510(k) clearance on 2017-06-22, under 510(k) number K171606.

Who is the listed applicant for AOS Anterolateral Proximal Humeral Plate?

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

What is the FDA product code for AOS Anterolateral Proximal Humeral Plate?

The FDA product code for AOS Anterolateral Proximal Humeral Plate is KTW.

Related Clinical Trials

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.

NCT07645768Is Anterior Reversed Proximal Humeral Locking Plate System (PHILOS) a Safe Alternative to Conventional Posterior Double Plating in Extra-Articular Distal Shaft Humeral FracturesACTIVE_NOT_RECRUITING

Other records listing Advanced Orthopaedic Solutions, Inc. (Aos) 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.

K181035AOS Small Fragment Plating System LiteK163014AOS Small Bone Nailing SystemK161913AOS Small Fragment Plating System

Related Devices (Code: KTW)

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.

K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd.K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc.

Official Source

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

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