Infinity OCT System, PASS OCT® Spinal System— 510(k) K210449

Substantially Equivalent

Medtronic

FDA 510(k) clearance K210449 for Infinity OCT System, PASS OCT® Spinal System, Substantially Equivalent on 2021-03-18. Applicant: Medtronic.

Clearance details

Applicant: Medtronic
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2021-02-16
Decision date: 2021-03-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.