The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for Carboclear Lumbar Cage System.
| Device ID | K193378 |
| 510k Number | K193378 |
| Device Name: | CarboClear Lumbar Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-05 |
| Decision Date | 2020-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110206666 | K193378 | 000 |
| 07290110206482 | K193378 | 000 |
| 07290110206475 | K193378 | 000 |
| 07290110206468 | K193378 | 000 |
| 07290110206451 | K193378 | 000 |
| 07290110206444 | K193378 | 000 |
| 07290110206437 | K193378 | 000 |
| 07290110206420 | K193378 | 000 |
| 07290110206413 | K193378 | 000 |
| 07290110206499 | K193378 | 000 |
| 07290110206574 | K193378 | 000 |
| 07290110206659 | K193378 | 000 |
| 07290110206642 | K193378 | 000 |
| 07290110206543 | K193378 | 000 |
| 07290110206536 | K193378 | 000 |
| 07290110206529 | K193378 | 000 |
| 07290110206512 | K193378 | 000 |
| 07290110206505 | K193378 | 000 |
| 07290110206628 | K193378 | 000 |
| 07290110208684 | K193378 | 000 |