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FDA 510(k)

HammerToe Compression System

K-Number: K183228 · 2019-01-25

ApplicantParagon 28, Inc.
Decision Date2019-01-25
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HammerToe Compression System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2019-01-25 under approval number K183228. 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 HammerToe Compression System?

HammerToe Compression System is a medical device that received FDA 510(k) clearance on 2019-01-25. It is manufactured by Paragon 28, Inc.. The 510(k) number is K183228.

When was HammerToe Compression System approved by the FDA?

HammerToe Compression System received FDA 510(k) clearance on 2019-01-25, under approval number K183228.

What company makes HammerToe Compression System?

HammerToe Compression System is manufactured by Paragon 28, Inc..

What is the FDA product code for HammerToe Compression System?

The FDA product code for HammerToe Compression System is 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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