Biopor Porous Polyethylene Implants— 510(k) K161446

Substantially Equivalent

Ceremed , Inc.

FDA 510(k) clearance K161446 for Biopor Porous Polyethylene Implants, Substantially Equivalent on 2016-09-27. Applicant: Ceremed , Inc..

Clearance details

Applicant: Ceremed , Inc.
Product code: Code GWO
Advisory panel: Neurology
Date received: 2016-05-25
Decision date: 2016-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.