ACCELL TBM-R— 510(k) K081817

Substantially Equivalent

Isotis Orthobiologics, Inc.

FDA 510(k) clearance K081817 for ACCELL TBM-R, Substantially Equivalent on 2008-09-24. Applicant: Isotis Orthobiologics, Inc.. Device class: 2.

Clearance details

Applicant: Isotis Orthobiologics, Inc.
Product code: Code MBP
Device class: Class 2
Regulation: 21 CFR 888.3045
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 ↗

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