Cleared Special

K060393 - INION HEXALON BIODEGRADABLE ACL/PCL SCREW
(FDA 510(k) Clearance)

K060393 · Inion , Ltd. · Orthopedic

Mar 2006

Decision

26d

Days

Class 2

Risk

K060393 is an FDA 510(k) clearance for the INION HEXALON BIODEGRADABLE ACL/PCL SCREW. 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 March 13, 2006, 26 days after receiving the submission on February 15, 2006.

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

Submission Details

510(k) Number	K060393 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 2006
Decision Date	March 13, 2006
Days to Decision	26 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF