The following data is part of a premarket notification filed by Carbofix Orthpedics Ltd. with the FDA for Carboclear Lumbar Cage System.
| Device ID | K203683 |
| 510k Number | K203683 |
| Device Name: | CarboClear Lumbar Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | CarboFix Orthpedics Ltd. 11 Ha'Hoshlim Street Herzeliya, IL 4672411 |
| Contact | Hila Wachsler-avrahami |
| Correspondent | Hila Wachsler-avrahami CarboFix Orthpedics Ltd. 11 Ha'Hoshlim Street Herzeliya, IL 4672411 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-17 |
| Decision Date | 2021-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110208745 | K203683 | 000 |
| 07290110208769 | K203683 | 000 |
| 07290110208776 | K203683 | 000 |
| 07290110208783 | K203683 | 000 |
| 07290110208790 | K203683 | 000 |
| 07290110208806 | K203683 | 000 |
| 07290110208813 | K203683 | 000 |
| 07290110208820 | K203683 | 000 |
| 07290110208837 | K203683 | 000 |
| 07290110208844 | K203683 | 000 |
| 07290110208714 | K203683 | 000 |
| 07290110208721 | K203683 | 000 |
| 07290110208738 | K203683 | 000 |
| 07290110208752 | K203683 | 000 |