THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM— 510(k) K013050

Substantially Equivalent

Bioplate, Inc.

FDA 510(k) clearance K013050 for THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM, Substantially Equivalent on 2001-12-10. Applicant: Bioplate, Inc..

Clearance details

Applicant: Bioplate, Inc.
Product code: Code GXN
Advisory panel: Neurology
Date received: 2001-09-11
Decision date: 2001-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

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.