X-STEN MILD TOOL KIT, MODEL MTK-0001— 510(k) K062038

Substantially Equivalent

X-Sten Corp.

FDA 510(k) clearance K062038 for X-STEN MILD TOOL KIT, MODEL MTK-0001, Substantially Equivalent on 2006-12-19. Applicant: X-Sten Corp..

Clearance details

Applicant: X-Sten Corp.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2006-07-19
Decision date: 2006-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.