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FDA 510(k)

BI-MENTUM dual mobility system

K-Number: K181744 · 2018-12-11

ApplicantSerf
Decision Date2018-12-11
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BI-MENTUM dual mobility system is a medical device manufactured by Serf. It received FDA 510(k) clearance on 2018-12-11 under approval number K181744. 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 dual mobility system?

BI-MENTUM dual mobility system is a medical device that received FDA 510(k) clearance on 2018-12-11. It is manufactured by Serf. The 510(k) number is K181744.

When was BI-MENTUM dual mobility system approved by the FDA?

BI-MENTUM dual mobility system received FDA 510(k) clearance on 2018-12-11, under approval number K181744.

What company makes BI-MENTUM dual mobility system?

BI-MENTUM dual mobility system is manufactured by Serf.

What is the FDA product code for BI-MENTUM dual mobility system?

The FDA product code for BI-MENTUM dual mobility system 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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