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FDA 510(k)

AOS Small Fragment Plating System Lite

K-Number: K181035 · 2018-08-24

ApplicantAdvanced Orthopaedic Solutions, Inc. (Aos)
Decision Date2018-08-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AOS Small Fragment Plating System Lite 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 2018-08-24 under 510(k) number K181035. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AOS Small Fragment Plating System Lite?

AOS Small Fragment Plating System Lite is a medical device that received FDA 510(k) clearance on 2018-08-24. The listed applicant is Advanced Orthopaedic Solutions, Inc. (Aos). The 510(k) number is K181035.

When did AOS Small Fragment Plating System Lite receive FDA 510(k) clearance?

AOS Small Fragment Plating System Lite received FDA 510(k) clearance on 2018-08-24, under 510(k) number K181035.

Who is the listed applicant for AOS Small Fragment Plating System Lite?

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 Small Fragment Plating System Lite?

The FDA product code for AOS Small Fragment Plating System Lite is HRS.

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.

K171606AOS Anterolateral Proximal Humeral PlateK163014AOS Small Bone Nailing SystemK161913AOS Small Fragment Plating System

Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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