BIOMET CRANIOFACIAL ACRYLIC CEMENT— 510(k) K011399

Name: FDA 510(k) clearance K011399
Creator: U.S. Food and Drug Administration
Published: 2003-05-05

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K011399 for BIOMET CRANIOFACIAL ACRYLIC CEMENT, Substantially Equivalent on 2003-05-05. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 2001-05-07
Decision date: 2003-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, 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.