The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for Carboclear Vbr System.
| Device ID | K192214 |
| 510k Number | K192214 |
| Device Name: | CarboClear VBR System |
| Classification | Spinal Vertebral Body Replacement Device |
| 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 | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-15 |
| Decision Date | 2019-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110206147 | K192214 | 000 |
| 07290110205942 | K192214 | 000 |
| 07290110205935 | K192214 | 000 |
| 07290110205928 | K192214 | 000 |
| 07290110205911 | K192214 | 000 |
| 07290110205904 | K192214 | 000 |
| 07290110205898 | K192214 | 000 |
| 07290110205881 | K192214 | 000 |
| 07290110205874 | K192214 | 000 |
| 07290110205867 | K192214 | 000 |
| 07290110205850 | K192214 | 000 |
| 07290110205843 | K192214 | 000 |
| 07290110205836 | K192214 | 000 |
| 07290110205829 | K192214 | 000 |
| 07290110205812 | K192214 | 000 |
| 07290110205805 | K192214 | 000 |
| 07290110205799 | K192214 | 000 |
| 07290110205782 | K192214 | 000 |
| 07290110205959 | K192214 | 000 |
| 07290110205966 | K192214 | 000 |
| 07290110206130 | K192214 | 000 |
| 07290110206123 | K192214 | 000 |
| 07290110206116 | K192214 | 000 |
| 07290110206109 | K192214 | 000 |
| 07290110206093 | K192214 | 000 |
| 07290110206086 | K192214 | 000 |
| 07290110206079 | K192214 | 000 |
| 07290110206062 | K192214 | 000 |
| 07290110206055 | K192214 | 000 |
| 07290110206048 | K192214 | 000 |
| 07290110206031 | K192214 | 000 |
| 07290110206024 | K192214 | 000 |
| 07290110206017 | K192214 | 000 |
| 07290110206000 | K192214 | 000 |
| 07290110205997 | K192214 | 000 |
| 07290110205980 | K192214 | 000 |
| 07290110205973 | K192214 | 000 |
| 07290110209841 | K192214 | 000 |