FDA 510(k)

Biocore9 Femoral Head Resurfacing Component

K-Number: K201219 · 2021-01-19

Decision Date2021-01-19

Product CodeKXA

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Biocore9 Femoral Head Resurfacing Component is a medical device manufactured by Biocore9, LLC. It received FDA 510(k) clearance on 2021-01-19 under approval number K201219. The device is classified under product code KXA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biocore9 Femoral Head Resurfacing Component?

Biocore9 Femoral Head Resurfacing Component is a medical device that received FDA 510(k) clearance on 2021-01-19. It is manufactured by Biocore9, LLC. The 510(k) number is K201219.

When was Biocore9 Femoral Head Resurfacing Component approved by the FDA?

Biocore9 Femoral Head Resurfacing Component received FDA 510(k) clearance on 2021-01-19, under approval number K201219.

What company makes Biocore9 Femoral Head Resurfacing Component?

Biocore9 Femoral Head Resurfacing Component is manufactured by Biocore9, LLC.

What is the FDA product code for Biocore9 Femoral Head Resurfacing Component?

The FDA product code for Biocore9 Femoral Head Resurfacing Component is KXA.

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Other Devices by Biocore9, LLC

K193122Biocore9 Humeral Resurfacing System K212761Biocore9 Acetabular Cup System

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.