Cleared Special

K090177 - INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE
(FDA 510(k) Clearance)

K090177 · Inion OY · Orthopedic

Feb 2009

Decision

28d

Days

Class 2

Risk

K090177 is an FDA 510(k) clearance for the INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on February 20, 2009, 28 days after receiving the submission on January 23, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K090177 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 2009
Decision Date	February 20, 2009
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF