MICROFIX

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

FIXANO SA

The following data is part of a premarket notification filed by Fixano Sa with the FDA for Microfix.

Pre-market Notification Details

• Device ID: K023314
• 510k Number: K023314
• Device Name: MICROFIX
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: FIXANO SA P.O BOX 12038 La Jolla, CA 92039 -2038
• Contact: Frank Ferguson
• Correspondent: Frank Ferguson; FIXANO SA P.O BOX 12038 La Jolla, CA 92039 -2038
• Product Code: KTT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-09-03
• Decision Date: 2002-10-18
• Summary: summary