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FDA 510(k)

Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

K-Number: K212431 · 2022-02-07

ApplicantBiomet, Inc.
Decision Date2022-02-07
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2022-02-07 under 510(k) number K212431. The device is classified under product code JDG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve?

Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve is a medical device that received FDA 510(k) clearance on 2022-02-07. The listed applicant is Biomet, Inc.. The 510(k) number is K212431.

When did Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve receive FDA 510(k) clearance?

Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve received FDA 510(k) clearance on 2022-02-07, under 510(k) number K212431.

Who is the listed applicant for Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve?

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 Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve?

The FDA product code for Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve is JDG.

Other records listing Biomet, Inc. as applicant

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Related Devices (Code: JDG)

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.

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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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