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
07290117353660	K200883	000
07290110206987	K200883	000
07290110206994	K200883	000
07290110207007	K200883	000
07290110207014	K200883	000
07290110207021	K200883	000
07290110207038	K200883	000
07290110207045	K200883	000
07290110207052	K200883	000
07290110207069	K200883	000
07290110207076	K200883	000
07290110207083	K200883	000
07290110206970	K200883	000
07290110206963	K200883	000
07290110206956	K200883	000
07290117353677	K200883	000
07290117353684	K200883	000
07290117353691	K200883	000
07290117353707	K200883	000
07290117351277	K200883	000
07290110206895	K200883	000
07290110206901	K200883	000
07290110206918	K200883	000
07290110206925	K200883	000
07290110206932	K200883	000
07290110206949	K200883	000
07290110207090	K200883	000
07290110207106	K200883	000
07290110207113	K200883	000
07290110207236	K200883	000
07290110207243	K200883	000
07290110207250	K200883	000
07290110207267	K200883	000
07290110207274	K200883	000
07290110207281	K200883	000
07290110207298	K200883	000
07290110207304	K200883	000
07290110207311	K200883	000
07290110207328	K200883	000
07290110207335	K200883	000
07290110207229	K200883	000
07290110207212	K200883	000
07290110207205	K200883	000
07290110207120	K200883	000
07290110207137	K200883	000
07290110208653	K200883	000
07290110208547	K200883	000
07290110208554	K200883	000
07290110207144	K200883	000
07290110207151	K200883	000
07290110207168	K200883	000
07290110207175	K200883	000
07290110207182	K200883	000
07290110207199	K200883	000
07290110207342	K200883	000