ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System— 510(k) K223301

Substantially Equivalent

Spinecraft, LLC

FDA 510(k) clearance K223301 for ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System, Substantially Equivalent on 2023-07-20. Applicant: Spinecraft, LLC.

Clearance details

Applicant: Spinecraft, LLC
Product code: Code OLO
Advisory panel: Neurology
Date received: 2022-10-27
Decision date: 2023-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

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.