ELEOS Limb Salvage System with BioGrip— 510(k) K203815

Substantially Equivalent

Onkos Surgical

FDA 510(k) clearance K203815 for ELEOS Limb Salvage System with BioGrip, Substantially Equivalent on 2021-06-09. Applicant: Onkos Surgical.

Clearance details

Applicant: Onkos Surgical
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 2020-12-29
Decision date: 2021-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.