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FDA 510(k)

Biocore9 Humeral Resurfacing System

K-Number: K193122 · 2020-05-15

ApplicantBiocore9, LLC
Decision Date2020-05-15
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Biocore9 Humeral Resurfacing System is a medical device manufactured by Biocore9, LLC. It received FDA 510(k) clearance on 2020-05-15 under approval number K193122. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biocore9 Humeral Resurfacing System?

Biocore9 Humeral Resurfacing System is a medical device that received FDA 510(k) clearance on 2020-05-15. It is manufactured by Biocore9, LLC. The 510(k) number is K193122.

When was Biocore9 Humeral Resurfacing System approved by the FDA?

Biocore9 Humeral Resurfacing System received FDA 510(k) clearance on 2020-05-15, under approval number K193122.

What company makes Biocore9 Humeral Resurfacing System?

Biocore9 Humeral Resurfacing System is manufactured by Biocore9, LLC.

What is the FDA product code for Biocore9 Humeral Resurfacing System?

The FDA product code for Biocore9 Humeral Resurfacing System is HSD.

Related Clinical Trials

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Other Devices by Biocore9, LLC

K201219Biocore9 Femoral Head Resurfacing Component K212761Biocore9 Acetabular Cup System

Related Devices (Code: HSD)

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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.

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