ASTRA-OCT Spine System— 510(k) K181350

Substantially Equivalent

Spinecraft, LLC

FDA 510(k) clearance K181350 for ASTRA-OCT Spine System, Substantially Equivalent on 2018-07-06. Applicant: Spinecraft, LLC.

Clearance details

Applicant: Spinecraft, LLC
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2018-05-22
Decision date: 2018-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, 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.