Cleared Traditional

K030900 - INION OTPS BIODEGRADABLE FIXATON SYSTEM
(FDA 510(k) Clearance)

K030900 · Inion , Ltd. · Orthopedic

Jun 2003

Decision

87d

Days

Class 2

Risk

K030900 is an FDA 510(k) clearance for the INION OTPS BIODEGRADABLE FIXATON SYSTEM. This device is classified as a Screw, Fixation, Bone (Class II — Special Controls, product code HWC).

Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on June 19, 2003, 87 days after receiving the submission on March 24, 2003.

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

Submission Details

510(k) Number	K030900 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 2003
Decision Date	June 19, 2003
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF