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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 a medical device manufactured by Paragon 28. It received FDA 510(k) clearance on 2018-03-05 under approval 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. It is manufactured by Paragon 28. The 510(k) number is K171715.

When was HammerTube System approved by the FDA?

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

What company makes HammerTube System?

HammerTube System is manufactured by Paragon 28.

What is the FDA product code for HammerTube System?

The FDA product code for HammerTube System is HTY.

Other Devices by Paragon 28

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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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