Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Arthrex DynaNite Nitinol Staple

K-Number: K172052 · 2017-12-13

ApplicantArthrex, Inc.
Decision Date2017-12-13
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex DynaNite Nitinol Staple is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2017-12-13 under approval number K172052. 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 Staple?

Arthrex DynaNite Nitinol Staple is a medical device that received FDA 510(k) clearance on 2017-12-13. It is manufactured by Arthrex, Inc.. The 510(k) number is K172052.

When was Arthrex DynaNite Nitinol Staple approved by the FDA?

Arthrex DynaNite Nitinol Staple received FDA 510(k) clearance on 2017-12-13, under approval number K172052.

What company makes Arthrex DynaNite Nitinol Staple?

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

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

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

Other Devices by Arthrex, Inc.

View all 168 devices →

Related Devices (Code: JDR)

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.