Cleared Special

MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM

K062617 · Inion , Ltd. · Orthopedic
Oct 2006
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K062617 is an FDA 510(k) clearance for the MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on October 4, 2006, 29 days after receiving the submission on September 5, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K062617 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2006
Decision Date October 04, 2006
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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