CarboClear® Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

CarboFix Orthopedics Ltd.

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

Pre-market Notification Details

• Device ID: K182377
• 510k Number: K182377
• Device Name: CarboClear® Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya, IL 4672411
• Contact: Hila Wachsler-avrahami
• Correspondent: Hila Wachsler-avrahami; CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya, IL 4672411
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-08-31
• Decision Date: 2018-09-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290110205041	K182377	000
17290110201859	K182377	000
17290110201842	K182377	000
17290110201835	K182377	000
17290110201828	K182377	000
17290110201811	K182377	000
17290110201804	K182377	000
17290110201798	K182377	000
17290110201781	K182377	000
17290110201774	K182377	000
17290110201767	K182377	000
17290110201750	K182377	000
07290109336138	K182377	000
17290110201866	K182377	000
17290110201873	K182377	000
17290110201880	K182377	000
07290110205034	K182377	000
07290110205027	K182377	000
07290110205010	K182377	000
17290110204935	K182377	000
07290110202200	K182377	000
17290110201958	K182377	000
17290110201941	K182377	000
17290110201934	K182377	000
17290110201927	K182377	000
17290110201910	K182377	000
17290110201903	K182377	000
17290110201897	K182377	000
17290117350697	K182377	000