Cure™ OPEL-C Plate 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™ Opel-c Plate System.

Pre-market Notification Details

• Device ID: K181543
• 510k Number: K181543
• Device Name: Cure™ OPEL-C Plate 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: 2018-06-12
• Decision Date: 2018-08-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B167T114S041210	K181543	000
B167T114S041200	K181543	000
B167T114S041190	K181543	000
B167T114S041180	K181543	000
B167T114S041170	K181543	000
B167T114S041160	K181543	000
B1671100422000	K181543	000
B1671100412000	K181543	000