Cerafix Dura Substitute— 510(k) K161278

Substantially Equivalent

Acera Surgical, Inc.

FDA 510(k) clearance K161278 for Cerafix Dura Substitute, Substantially Equivalent on 2016-08-08. Applicant: Acera Surgical, Inc..

Clearance details

Applicant: Acera Surgical, Inc.
Product code: Code GXQ
Advisory panel: Neurology
Date received: 2016-05-06
Decision date: 2016-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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Adverse events under product code GXQ

product code GXQ

Death: 11
Injury: 446
Other: 1
Total: 458

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.