K081817

Substantially Equivalent

ACCELL TBM-R

Applicant: Isotis Orthobiologics, Inc.
Product code: MBP
Advisory panel: Orthopedic
Date received: 2008-06-26
Decision date: 2008-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planisboro, NJ, US

Download summary PDF View on FDA.gov ↗

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