ACCELL EVO3C— 510(k) K091193

Substantially Equivalent

Isotis Orthobiologics, Inc.

FDA 510(k) clearance K091193 for ACCELL EVO3C, Substantially Equivalent on 2009-08-10. Applicant: Isotis Orthobiologics, Inc..

Clearance details

Applicant: Isotis Orthobiologics, Inc.
Product code: Code MBP
Advisory panel: Orthopedic
Date received: 2009-04-23
Decision date: 2009-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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