FDA 510(k)

BI-MENTUM ALTRX® Dual Mobility Liner

K-Number: K203532 · 2021-04-28

Decision Date2021-04-28

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BI-MENTUM ALTRX® Dual Mobility Liner is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2021-04-28 under approval number K203532. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BI-MENTUM ALTRX® Dual Mobility Liner?

BI-MENTUM ALTRX® Dual Mobility Liner is a medical device that received FDA 510(k) clearance on 2021-04-28. It is manufactured by Depuy Ireland UC. The 510(k) number is K203532.

When was BI-MENTUM ALTRX® Dual Mobility Liner approved by the FDA?

BI-MENTUM ALTRX® Dual Mobility Liner received FDA 510(k) clearance on 2021-04-28, under approval number K203532.

What company makes BI-MENTUM ALTRX® Dual Mobility Liner?

BI-MENTUM ALTRX® Dual Mobility Liner is manufactured by Depuy Ireland UC.

What is the FDA product code for BI-MENTUM ALTRX® Dual Mobility Liner?

The FDA product code for BI-MENTUM ALTRX® Dual Mobility Liner is LZO.

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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.