ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY— 510(k) K060306

Name: FDA 510(k) clearance K060306
Creator: U.S. Food and Drug Administration
Published: 2006-03-27

Substantially Equivalent

Isotis NV

FDA 510(k) clearance K060306 for ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY, Substantially Equivalent on 2006-03-27. Applicant: Isotis NV. Device class: 2.

Clearance details

Applicant: Isotis NV
Product code: Code NUN
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2006-02-07
Decision date: 2006-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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