Surgical Navigation Advanced Platform (SNAP)— 510(k) K160584

Substantially Equivalent

Surgical Theater, LLC

FDA 510(k) clearance K160584 for Surgical Navigation Advanced Platform (SNAP), Substantially Equivalent on 2016-06-28. Applicant: Surgical Theater, LLC.

Clearance details

Applicant: Surgical Theater, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-03-01
Decision date: 2016-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mayfield Village, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.