Cleared Traditional

K063410 - INION CPS/OTPS FREEDOMPLATE
(FDA 510(k) Clearance)

K063410 · Inion , Ltd. · Orthopedic

Jan 2007

Decision

71d

Days

Class 2

Risk

K063410 is an FDA 510(k) clearance for the INION CPS/OTPS FREEDOMPLATE. This device is classified as a Plate, Fixation, Bone (Class II — Special Controls, product code HRS).

Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on January 23, 2007, 71 days after receiving the submission on November 13, 2006.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K063410 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2006
Decision Date	January 23, 2007
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF