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FDA 510(k)

HammerTube System

K-Number: K171715 · 2018-03-05

ApplicantParagon 28
Decision Date2018-03-05
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HammerTube System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28. It received FDA 510(k) clearance on 2018-03-05 under 510(k) number K171715. 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 HammerTube System?

HammerTube System is a medical device that received FDA 510(k) clearance on 2018-03-05. The listed applicant is Paragon 28. The 510(k) number is K171715.

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

HammerTube System received FDA 510(k) clearance on 2018-03-05, under 510(k) number K171715.

Who is the listed applicant for HammerTube System?

The FDA 510(k) record lists Paragon 28 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HammerTube System?

The FDA product code for HammerTube System is HTY.

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Related Devices (Code: HTY)

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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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