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FDA 510(k)

TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System

K-Number: K173811 · 2018-03-15

ApplicantIn2bones Sas
Decision Date2018-03-15
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2018-03-15 under 510(k) number K173811. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System?

TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System is a medical device that received FDA 510(k) clearance on 2018-03-15. The listed applicant is In2bones Sas. The 510(k) number is K173811.

When did TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System receive FDA 510(k) clearance?

TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System received FDA 510(k) clearance on 2018-03-15, under 510(k) number K173811.

Who is the listed applicant for TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System?

The FDA product code for TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System is HSB.

Other records listing In2bones Sas as applicant

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Related Devices (Code: HSB)

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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