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FDA 510(k)

G7® Vivacit-E® Freedom® Constrained Liner

K-Number: K212512 · 2022-04-28

ApplicantZimmer, Inc.
Decision Date2022-04-28
Product CodePBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G7® Vivacit-E® Freedom® Constrained Liner is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2022-04-28 under 510(k) number K212512. The device is classified under product code PBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G7® Vivacit-E® Freedom® Constrained Liner?

G7® Vivacit-E® Freedom® Constrained Liner is a medical device that received FDA 510(k) clearance on 2022-04-28. The listed applicant is Zimmer, Inc.. The 510(k) number is K212512.

When did G7® Vivacit-E® Freedom® Constrained Liner receive FDA 510(k) clearance?

G7® Vivacit-E® Freedom® Constrained Liner received FDA 510(k) clearance on 2022-04-28, under 510(k) number K212512.

Who is the listed applicant for G7® Vivacit-E® Freedom® Constrained Liner?

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

What is the FDA product code for G7® Vivacit-E® Freedom® Constrained Liner?

The FDA product code for G7® Vivacit-E® Freedom® Constrained Liner is PBI.

Other records listing Zimmer, Inc. as applicant

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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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