CarboClear® Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Carbofix Orthopedics Ltd.

The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for Carboclear® Cervical Plate System.

Pre-market Notification Details

• Device ID: K200883
• 510k Number: K200883
• Device Name: CarboClear® Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Carbofix Orthopedics Ltd. 11 Ha'Hoshlim St. Herzeliya, IL 4672411
• Contact: Yael Rubin
• Correspondent: Yael Rubin; Carbofix Orthopedics Ltd. 11 Ha'Hoshlim St. Herzeliya, IL 4672411
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-02
• Decision Date: 2020-06-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290117351277	K200883	000
07290110207021	K200883	000
07290110207038	K200883	000
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07290110207342	K200883	000