XTOOL— 510(k) K122861

Substantially Equivalent

Ouroboros Medical

FDA 510(k) clearance K122861 for XTOOL, Substantially Equivalent on 2012-12-07. Applicant: Ouroboros Medical.

Clearance details

Applicant: Ouroboros Medical
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2012-09-18
Decision date: 2012-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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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.