Cleared Traditional

K052624 - INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE
(FDA 510(k) Clearance)

K052624 · Inion , Ltd. · Orthopedic

Nov 2005

Decision

54d

Days

Class 2

Risk

K052624 is an FDA 510(k) clearance for the INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE. 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 November 16, 2005, 54 days after receiving the submission on September 23, 2005.

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

Submission Details

510(k) Number	K052624 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2005
Decision Date	November 16, 2005
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF