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FDA 510(k)

Arthrex DynaNite Nitinol Staples

K-Number: K243742 · 2025-01-31

ApplicantArthrex, Inc.
Decision Date2025-01-31
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex DynaNite Nitinol 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 2025-01-31 under 510(k) number K243742. 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 Nitinol Staples?

Arthrex DynaNite Nitinol Staples is a medical device that received FDA 510(k) clearance on 2025-01-31. The listed applicant is Arthrex, Inc.. The 510(k) number is K243742.

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

Arthrex DynaNite Nitinol Staples received FDA 510(k) clearance on 2025-01-31, under 510(k) number K243742.

Who is the listed applicant for Arthrex DynaNite Nitinol 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 Nitinol Staples?

The FDA product code for Arthrex DynaNite Nitinol Staples is JDR.

Other records listing Arthrex, Inc. as applicant

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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, LPK243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical ConceptsK240212COGNiTiON™ Staple SystemOrtho Solutions UK , Ltd.

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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