ODALYS Pedicle Screw System— 510(k) K152098

Substantially Equivalent

Kisco International

FDA 510(k) clearance K152098 for ODALYS Pedicle Screw System, Substantially Equivalent on 2015-09-17. Applicant: Kisco International.

Clearance details

Applicant: Kisco International
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2015-07-28
Decision date: 2015-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint-Priest, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.