MINI MAXLOCK EXTREME PLATING 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 Mini Maxlock Extreme Plating System.

Pre-market Notification Details

• Device ID: K120157
• 510k Number: K120157
• Device Name: MINI MAXLOCK EXTREME PLATING 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-18
• Decision Date: 2012-04-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00846832044993	K120157	000
00846832044986	K120157	000
00846832044979	K120157	000
00846832044931	K120157	000