AXSOS PLUS LOCKING PLATE SYSTEM

Plate, Fixation, Bone

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Axsos Plus Locking Plate System.

Pre-market Notification Details

• Device ID: K061012
• 510k Number: K061012
• Device Name: AXSOS PLUS LOCKING PLATE SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430
• Contact: Francisco Haro
• Correspondent: Francisco Haro; HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-04-12
• Decision Date: 2006-05-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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