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FDA 510(k)

AOS Anterolateral Proximal Humeral Plate

K-Number: K160409 · 2016-03-15

ApplicantAdvanced Orthopaedic Solutions, Inc.
Decision Date2016-03-15
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.. It received FDA 510(k) clearance on 2016-03-15 under 510(k) number K160409. 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 2016-03-15. The listed applicant is Advanced Orthopaedic Solutions, Inc.. The 510(k) number is K160409.

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

AOS Anterolateral Proximal Humeral Plate received FDA 510(k) clearance on 2016-03-15, under 510(k) number K160409.

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

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 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. 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 SystemK191598AOS ES Retrograde Femoral NailK182466AOS Calcaneal 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.K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos)K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.

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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