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FDA 510(k)

Arthrex DynaNite Staples

K-Number: K262451 · 2026-09-01

ApplicantArthrex, Inc.
Decision Date2026-09-01
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex DynaNite Staples is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2026-09-01 under 510(k) number K262451. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex DynaNite Staples?

Arthrex DynaNite Staples is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Arthrex, Inc.. The 510(k) number is K262451.

When did Arthrex DynaNite Staples receive FDA 510(k) clearance?

Arthrex DynaNite Staples received FDA 510(k) clearance on 2026-09-01, under 510(k) number K262451.

Who is the listed applicant for Arthrex DynaNite Staples?

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

What is the FDA product code for Arthrex DynaNite Staples?

The FDA product code for Arthrex DynaNite Staples is JDR.

Other records listing Arthrex, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JDR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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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