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 the device name listed in this FDA 510(k) record. The listed applicant is Biocore9, LLC. It received FDA 510(k) clearance on 2021-01-19 under 510(k) 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. The listed applicant is Biocore9, LLC. The 510(k) number is K201219.

When did Biocore9 Femoral Head Resurfacing Component receive FDA 510(k) clearance?

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

Who is the listed applicant for Biocore9 Femoral Head Resurfacing Component?

The FDA 510(k) record lists Biocore9, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Biocore9, LLC 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.

K212761Biocore9 Acetabular Cup System K193122Biocore9 Humeral Resurfacing System

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.