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FDA 510(k)

G7 Dual Mobility System, Active Articulation System

K-Number: K161190 · 2016-05-26

ApplicantBiomet, Inc.
Decision Date2016-05-26
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G7 Dual Mobility System, Active Articulation System is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2016-05-26 under approval number K161190. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G7 Dual Mobility System, Active Articulation System?

G7 Dual Mobility System, Active Articulation System is a medical device that received FDA 510(k) clearance on 2016-05-26. It is manufactured by Biomet, Inc.. The 510(k) number is K161190.

When was G7 Dual Mobility System, Active Articulation System approved by the FDA?

G7 Dual Mobility System, Active Articulation System received FDA 510(k) clearance on 2016-05-26, under approval number K161190.

What company makes G7 Dual Mobility System, Active Articulation System?

G7 Dual Mobility System, Active Articulation System is manufactured by Biomet, Inc..

What is the FDA product code for G7 Dual Mobility System, Active Articulation System?

The FDA product code for G7 Dual Mobility System, Active Articulation System is LPH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.