FDA 510(k)

Summit Patella Plating System

K-Number: K203408 · 2021-07-30

Decision Date2021-07-30

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Summit Patella Plating System is a medical device manufactured by Endeavor Orthopaedics, LLC. It received FDA 510(k) clearance on 2021-07-30 under approval number K203408. 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 Summit Patella Plating System?

Summit Patella Plating System is a medical device that received FDA 510(k) clearance on 2021-07-30. It is manufactured by Endeavor Orthopaedics, LLC. The 510(k) number is K203408.

When was Summit Patella Plating System approved by the FDA?

Summit Patella Plating System received FDA 510(k) clearance on 2021-07-30, under approval number K203408.

What company makes Summit Patella Plating System?

Summit Patella Plating System is manufactured by Endeavor Orthopaedics, LLC.

What is the FDA product code for Summit Patella Plating System?

The FDA product code for Summit Patella Plating System is HRS.

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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.