Arthrex DynaNite Nitinol Staple— 510(k) K172052

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K172052 for Arthrex DynaNite Nitinol Staple, Substantially Equivalent on 2017-12-13. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2017-07-06
Decision date: 2017-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.