MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM— 510(k) K070901

Substantially Equivalent

Bioplate, Inc.

FDA 510(k) clearance K070901 for MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM, Substantially Equivalent on 2007-06-15. Applicant: Bioplate, Inc..

Clearance details

Applicant: Bioplate, Inc.
Product code: Code GXN
Advisory panel: Neurology
Date received: 2007-04-02
Decision date: 2007-06-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Los Angeles, CA, US

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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.