ZX-I POWER ADD ON— 510(k) K123769

Substantially Equivalent

Spinergy, Inc.

FDA 510(k) clearance K123769 for ZX-I POWER ADD ON, Substantially Equivalent on 2013-05-10. Applicant: Spinergy, Inc..

Clearance details

Applicant: Spinergy, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2012-12-07
Decision date: 2013-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.