ORTHOBLAST II PUTTY AND PASTE— 510(k) K050642

Name: FDA 510(k) clearance K050642
Creator: U.S. Food and Drug Administration
Published: 2005-12-05

Substantially Equivalent

Isotis Orthobiologics, Inc.

FDA 510(k) clearance K050642 for ORTHOBLAST II PUTTY AND PASTE, Substantially Equivalent on 2005-12-05. 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: 2005-03-11
Decision date: 2005-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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