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FDA 510(k)

AOS Calcaneal Plating System

K-Number: K182466 · 2018-10-30

ApplicantAdvanced Orthopaedic Solutions
Decision Date2018-10-30
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AOS Calcaneal Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions. It received FDA 510(k) clearance on 2018-10-30 under 510(k) number K182466. 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 Calcaneal Plating System?

AOS Calcaneal Plating System is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is Advanced Orthopaedic Solutions. The 510(k) number is K182466.

When did AOS Calcaneal Plating System receive FDA 510(k) clearance?

AOS Calcaneal Plating System received FDA 510(k) clearance on 2018-10-30, under 510(k) number K182466.

Who is the listed applicant for AOS Calcaneal Plating System?

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

What is the FDA product code for AOS Calcaneal Plating System?

The FDA product code for AOS Calcaneal Plating System is HRS.

Other records listing Advanced Orthopaedic Solutions 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 NailK160409AOS Anterolateral Proximal Humeral Plate

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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