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FDA 510(k)

TunneLoc Tibial Fixation Device

K-Number: K193092 · 2020-01-02

ApplicantBiomet, Inc.
Decision Date2020-01-02
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TunneLoc Tibial Fixation Device is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K193092. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TunneLoc Tibial Fixation Device?

TunneLoc Tibial Fixation Device is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Biomet, Inc.. The 510(k) number is K193092.

When did TunneLoc Tibial Fixation Device receive FDA 510(k) clearance?

TunneLoc Tibial Fixation Device received FDA 510(k) clearance on 2020-01-02, under 510(k) number K193092.

Who is the listed applicant for TunneLoc Tibial Fixation Device?

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 TunneLoc Tibial Fixation Device?

The FDA product code for TunneLoc Tibial Fixation Device is MBI.

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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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