XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm— 510(k) K260073

Substantially Equivalent

Biodynamik, Inc.

FDA 510(k) clearance K260073 for XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm, Substantially Equivalent on 2026-02-10. Applicant: Biodynamik, Inc..

Clearance details

Applicant: Biodynamik, Inc.
Product code: Code JDW
Advisory panel: Orthopedic
Date received: 2026-01-09
Decision date: 2026-02-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.