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FDA 510(k)

Primal K-Wire (P99-193-1410)

K-Number: K262722 · 2026-08-28

ApplicantParagon 28, Inc.
Decision Date2026-08-28
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Primal K-Wire (P99-193-1410) is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2026-08-28 under 510(k) number K262722. 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 Primal K-Wire (P99-193-1410)?

Primal K-Wire (P99-193-1410) is a medical device that received FDA 510(k) clearance on 2026-08-28. The listed applicant is Paragon 28, Inc.. The 510(k) number is K262722.

When did Primal K-Wire (P99-193-1410) receive FDA 510(k) clearance?

Primal K-Wire (P99-193-1410) received FDA 510(k) clearance on 2026-08-28, under 510(k) number K262722.

Who is the listed applicant for Primal K-Wire (P99-193-1410)?

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

What is the FDA product code for Primal K-Wire (P99-193-1410)?

The FDA product code for Primal K-Wire (P99-193-1410) 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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