Cleared Traditional

K123672 - INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
(FDA 510(k) Clearance)

K123672 · Inion OY · Orthopedic

Feb 2013

Decision

90d

Days

Class 2

Risk

K123672 is an FDA 510(k) clearance for the INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW). This device is classified as a Screw, Fixation, Bone (Class II — Special Controls, product code HWC).

Submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on February 27, 2013, 90 days after receiving the submission on November 29, 2012.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K123672 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2012
Decision Date	February 27, 2013
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF