HOFFMANN II FOOT RING

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

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Hoffmann Ii Foot Ring.

Pre-market Notification Details

• Device ID: K041706
• 510k Number: K041706
• Device Name: HOFFMANN II FOOT RING
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430
• Contact: Vivian Kelly
• Correspondent: Vivian Kelly; HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430
• Product Code: KTT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-06-23
• Decision Date: 2004-09-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613154082247	K041706	000
04546540701831	K041706	000
04546540701824	K041706	000
04546540701817	K041706	000