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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 the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2016-05-26 under 510(k) 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. The listed applicant is Biomet, Inc.. The 510(k) number is K161190.

When did G7 Dual Mobility System, Active Articulation System receive FDA 510(k) clearance?

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

Who is the listed applicant for G7 Dual Mobility System, Active Articulation System?

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

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.

Other records listing Biomet, Inc. as applicant

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Related Devices (Code: LPH)

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.

K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

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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