MAXLOCK EXTREME ELBOW FRACTURE 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 Elbow Fracture System.

Pre-market Notification Details

• Device ID: K141301
• 510k Number: K141301
• Device Name: MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: ORTHOHELIX SURGICAL DESIGNS, INC. 1065 Medina Rd. SUITE 500 Medina, OH 44256
• Contact: Brian Hockett
• Correspondent: Brian Hockett; 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: 2014-05-19
• Decision Date: 2014-07-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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