Rotium Bioresorbable Wick— 510(k) K231641

Substantially Equivalent

Nanofiber Solutions, LLC

FDA 510(k) clearance K231641 for Rotium Bioresorbable Wick, Substantially Equivalent on 2023-07-05. Applicant: Nanofiber Solutions, LLC.

Clearance details

Applicant: Nanofiber Solutions, LLC
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2023-06-05
Decision date: 2023-07-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Dublin, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.