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FDA 510(k)

DIP Arthrodesis System

K-Number: K173616 · 2018-01-19

ApplicantIn2bones Sas
Decision Date2018-01-19
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DIP 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 2018-01-19 under 510(k) number K173616. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIP Arthrodesis System?

DIP Arthrodesis System is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is In2bones Sas. The 510(k) number is K173616.

When did DIP Arthrodesis System receive FDA 510(k) clearance?

DIP Arthrodesis System received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173616.

Who is the listed applicant for DIP 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 DIP Arthrodesis System?

The FDA product code for DIP Arthrodesis System is HTY.

Other records listing In2bones Sas as applicant

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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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