OTS 25-L (100-5)— 510(k) K241234

Substantially Equivalent

Ots Medical , Ltd.

FDA 510(k) clearance K241234 for OTS 25-L (100-5), Substantially Equivalent on 2025-01-23. Applicant: Ots Medical , Ltd..

Clearance details

Applicant: Ots Medical , Ltd.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2024-05-02
Decision date: 2025-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.