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FDA 510(k)

BI-MENTUM™ ALTRX® Dual Mobility Liner

K-Number: K203532 · 2021-04-28

ApplicantDepuy Ireland UC
Decision Date2021-04-28
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BI-MENTUM™ ALTRX® Dual Mobility Liner is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2021-04-28 under 510(k) 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. The listed applicant is Depuy Ireland UC. The 510(k) number is K203532.

When did BI-MENTUM™ ALTRX® Dual Mobility Liner receive FDA 510(k) clearance?

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

Who is the listed applicant for BI-MENTUM™ ALTRX® Dual Mobility Liner?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

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.

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