Biolign® Roto-Loc Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Elite Surgical Supplies (PTY) LTD

The following data is part of a premarket notification filed by Elite Surgical Supplies (pty) Ltd with the FDA for Biolign® Roto-loc Cervical Plate System.

Pre-market Notification Details

• Device ID: K200523
• 510k Number: K200523
• Device Name: Biolign® Roto-Loc Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Elite Surgical Supplies (PTY) LTD 54 De Havilland Cresent, Persequor Technopark Pretoria, ZA 0020
• Contact: Thanos Spirakis
• Correspondent: Jordan Floyd; JALEX Medical 27865 Clemens Rd. Suite 3 Westlake, OH 44145
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-02
• Decision Date: 2020-04-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06009708424914	K200523	000
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06009708425690	K200523	000
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06009708420442	K200523	000