EDGELOCK

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 Edgelock.

Pre-market Notification Details

• Device ID: K093900
• 510k Number: K093900
• Device Name: EDGELOCK
• Classification: Plate, Fixation, Bone
• Applicant: ORTHOHELIX SURGICAL DESIGNS, INC. 1815 W. MARKET ST. SUITE 205 Akron, OH 44313
• Contact: Derek Lewis
• Correspondent: Derek Lewis; ORTHOHELIX SURGICAL DESIGNS, INC. 1815 W. MARKET ST. SUITE 205 Akron, OH 44313
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-12-18
• Decision Date: 2010-02-17
• Summary: summary