TZ SKULL PIN Adult— 510(k) K163322

Substantially Equivalent

Tz Medical, Inc.

FDA 510(k) clearance K163322 for TZ SKULL PIN Adult, Substantially Equivalent on 2017-02-23. Applicant: Tz Medical, Inc..

Clearance details

Applicant: Tz Medical, Inc.
Product code: Code HBL
Advisory panel: Neurology
Date received: 2016-11-25
Decision date: 2017-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBL

product code HBL

Death: 3
Injury: 753
Malfunction: 1,421
Total: 2,177

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.