Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AOS Calcaneal Plating System

K-Number: K182466 · 2018-10-30

Decision Date2018-10-30
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AOS Calcaneal Plating System is a medical device manufactured by Advanced Orthopaedic Solutions. It received FDA 510(k) clearance on 2018-10-30 under approval 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. It is manufactured by Advanced Orthopaedic Solutions. The 510(k) number is K182466.

When was AOS Calcaneal Plating System approved by the FDA?

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

What company makes AOS Calcaneal Plating System?

AOS Calcaneal Plating System is manufactured by Advanced Orthopaedic Solutions.

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

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

Related Devices (Code: HRS)

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.