Cure™ Lumbar 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™ Lumbar Plate System.

Pre-market Notification Details

• Device ID: K201136
• 510k Number: K201136
• Device Name: Cure™ Lumbar 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-28
• Decision Date: 2020-05-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B16790042145T0	K201136	000
B16790042133T0	K201136	000
B16790042132T0	K201136	000
B16790042131T0	K201136	000
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B16790042125T0	K201136	000
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B16790042144T0	K201136	000
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B16790042141T0	K201136	000
B16790042140T0	K201136	000
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B167900021290	K201136	000
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B167900021340	K201136	000
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B167900021430	K201136	000
B167900021420	K201136	000
B167900021410	K201136	000
B167900021400	K201136	000
B167900021390	K201136	000
B167900021380	K201136	000
B167900021370	K201136	000
B167900021360	K201136	000
B167900909160	K201136	000
B167S1900021450	K201136	000
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B167S1900021290	K201136	000
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B167S1900021270	K201136	000
B167S1900021260	K201136	000
B167S1900021250	K201136	000
B167S1900021340	K201136	000
B167S1900021350	K201136	000
B167S1900021440	K201136	000
B167S1900021430	K201136	000
B167S1900021420	K201136	000
B167S1900021410	K201136	000
B167S1900021400	K201136	000
B167S1900021390	K201136	000
B167S1900021380	K201136	000
B167S1900021370	K201136	000
B167S1900021360	K201136	000
B16790044245T0	K201136	000
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B16790044231T0	K201136	000
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B16790042900020	K201136	000
B16790042900010	K201136	000
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B16790044233T0	K201136	000
B16790044242T0	K201136	000
B16790044241T0	K201136	000
B16790044240T0	K201136	000
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B16790044238T0	K201136	000
B16790044237T0	K201136	000
B16790044236T0	K201136	000
B16790044235T0	K201136	000
B16790044234T0	K201136	000
B167900429000	K201136	000