MAXLOCK EXTREME SYSTEM

Plate, Fixation, Bone

ORTHOHELIX SURGICAL DESIGNS, INC.

The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Maxlock Extreme System.

Pre-market Notification Details

• Device ID: K113048
• 510k Number: K113048
• Device Name: MAXLOCK EXTREME SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: ORTHOHELIX SURGICAL DESIGNS, INC. 1065 Medina Rd. SUITE 500 Medina, OH 44256
• Contact: Derek Lewis
• Correspondent: Derek Lewis; ORTHOHELIX SURGICAL DESIGNS, INC. 1065 Medina Rd. SUITE 500 Medina, OH 44256
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-12
• Decision Date: 2012-01-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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