BioBrace ® RC Delivery System— 510(k) K250395

Name: FDA 510(k) clearance K250395
Creator: U.S. Food and Drug Administration
Published: 2025-04-07

Substantially Equivalent

Conmed Corporation

FDA 510(k) clearance K250395 for BioBrace ® RC Delivery System, Substantially Equivalent on 2025-04-07. Applicant: Conmed Corporation. Device class: 2.

Clearance details

Applicant: Conmed Corporation
Product code: Code ORQ
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2025-02-12
Decision date: 2025-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utica, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.