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FDA 510(k)

ToggleLoc System

K-Number: K173278 · 2018-01-05

ApplicantBiomet, Inc.
Decision Date2018-01-05
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ToggleLoc 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 2018-01-05 under 510(k) number K173278. 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 ToggleLoc System?

ToggleLoc System is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is Biomet, Inc.. The 510(k) number is K173278.

When did ToggleLoc System receive FDA 510(k) clearance?

ToggleLoc System received FDA 510(k) clearance on 2018-01-05, under 510(k) number K173278.

Who is the listed applicant for ToggleLoc 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 ToggleLoc System?

The FDA product code for ToggleLoc System 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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