ACE FISCHER EXTERNAL FIXATION SYSTEM

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

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Ace Fischer External Fixation System.

Pre-market Notification Details

• Device ID: K083789
• 510k Number: K083789
• Device Name: ACE FISCHER EXTERNAL FIXATION SYSTEM
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Suzana Otano
• Correspondent: Suzana Otano; DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Product Code: KTT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-19
• Decision Date: 2009-03-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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