Cure™ Anterior Cervical Plate (ACP) System

Appliance, Fixation, Spinal Intervertebral Body

MEDITECH SPINE, LLC

The following data is part of a premarket notification filed by Meditech Spine, Llc with the FDA for Cure™ Anterior Cervical Plate (acp) System.

Pre-market Notification Details

• Device ID: K160604
• 510k Number: K160604
• Device Name: Cure™ Anterior Cervical Plate (ACP) System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: MEDITECH SPINE, LLC 1447 PEACHTREE ST NE SUITE 440 Atlanta, GA 30309
• Contact: Bruce Dunaway
• Correspondent: Bruce Dunaway; MEDITECH SPINE, LLC 1447 PEACHTREE ST NE SUITE 440 Atlanta, GA 30309
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-02
• Decision Date: 2016-07-01
• Summary: summary

NIH GUDID Devices

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