AOS PROXIMAL HUMERAL PLATE

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

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Proximal Humeral Plate.

Pre-market Notification Details

• Device ID: K080590
• 510k Number: K080590
• Device Name: AOS PROXIMAL HUMERAL PLATE
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Single Component
• Applicant: ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 2444 205TH STREET, UNIT 5 Torrance, CA 90501
• Contact: Paul Doner
• Correspondent: Paul Doner; ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 2444 205TH STREET, UNIT 5 Torrance, CA 90501
• Product Code: KTW
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-03-03
• Decision Date: 2008-05-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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