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FDA 510(k)

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm

K-Number: K260073 · 2026-02-10

ApplicantBiodynamik, Inc.
Decision Date2026-02-10
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm is a medical device manufactured by Biodynamik, Inc.. It received FDA 510(k) clearance on 2026-02-10 under approval number K260073. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm?

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm is a medical device that received FDA 510(k) clearance on 2026-02-10. It is manufactured by Biodynamik, Inc.. The 510(k) number is K260073.

When was XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm approved by the FDA?

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm received FDA 510(k) clearance on 2026-02-10, under approval number K260073.

What company makes XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm?

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm is manufactured by Biodynamik, Inc..

What is the FDA product code for XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm?

The FDA product code for XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm is JDW.

Other Devices by Biodynamik, Inc.

K241357XT3 System

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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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