Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by In2bones Sas. It received FDA 510(k) clearance on 2018-03-15 under approval 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. It is manufactured by In2bones Sas. The 510(k) number is K173811.

When was TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System approved by the FDA?

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

What company makes TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System?

TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System is manufactured by In2bones Sas.

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 Devices by In2bones Sas

View all 14 devices →

Related Devices (Code: HSB)

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.