Cleared Traditional

K070998 - INION BIORESTORE
(FDA 510(k) Clearance)

K070998 · Inion OY · Orthopedic

Oct 2007

Decision

185d

Days

Class 2

Risk

K070998 is an FDA 510(k) clearance for the INION BIORESTORE, 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 October 11, 2007, 185 days after receiving the submission on April 9, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K070998 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 2007
Decision Date	October 11, 2007
Days to Decision	185 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF