CarboClear® Pedicle Screw System, CarboClear® II 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, Carboclear® Ii Pedicle Screw System.
Pre-market Notification Details
| Device ID | K201926 |
| 510k Number | K201926 |
| Device Name: | CarboClear® Pedicle Screw System, CarboClear® II 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 | 2020-07-10 |
| Decision Date | 2020-08-07 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110207663 | K201926 | 000 |
| 07290110207427 | K201926 | 000 |
| 07290110207410 | K201926 | 000 |
| 07290110207403 | K201926 | 000 |
| 07290110207397 | K201926 | 000 |
| 07290110207380 | K201926 | 000 |
Trademark Results [CarboClear]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARBOCLEAR 86654176 5283412 Live/Registered |
CarboFix In Orthopedics LLC 2015-06-07 |
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