FDA 510(k)

Arthrex DynaNite Nitinol Staples

K-Number: K243742 · 2025-01-31

Decision Date2025-01-31

Product CodeJDR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arthrex DynaNite Nitinol Staples is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2025-01-31 under approval 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. It is manufactured by Arthrex, Inc.. The 510(k) number is K243742.

When was Arthrex DynaNite Nitinol Staples approved by the FDA?

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

What company makes Arthrex DynaNite Nitinol Staples?

Arthrex DynaNite Nitinol Staples is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex DynaNite Nitinol Staples?

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

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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.