The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for High V+ Bone Cement, Carboclear® Fenestrated Pedicle Screws.
| Device ID | K190526 |
| 510k Number | K190526 |
| Device Name: | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws |
| Classification | Bone Cement, Posterior Screw Augmentation |
| 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 | PML |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110207519 | K190526 | 000 |
| 17290117350444 | K190526 | 000 |
| 17290117350437 | K190526 | 000 |
| 17290117350420 | K190526 | 000 |
| 17290117350413 | K190526 | 000 |
| 17290117350406 | K190526 | 000 |
| 17290117350390 | K190526 | 000 |
| 17290117350383 | K190526 | 000 |
| 17290117350376 | K190526 | 000 |
| 17290117350369 | K190526 | 000 |
| 17290117350352 | K190526 | 000 |
| 17290117350345 | K190526 | 000 |
| 17290117350321 | K190526 | 000 |
| 17290117350314 | K190526 | 000 |
| 17290117350307 | K190526 | 000 |
| 17290117350291 | K190526 | 000 |
| 17290117350284 | K190526 | 000 |
| 17290110204393 | K190526 | 000 |
| 17290110204409 | K190526 | 000 |
| 07290110207502 | K190526 | 000 |
| 07290110207496 | K190526 | 000 |
| 07290110207489 | K190526 | 000 |
| 07290110207472 | K190526 | 000 |
| 07290110207465 | K190526 | 000 |
| 07290110207458 | K190526 | 000 |
| 07290110207441 | K190526 | 000 |
| 07290110204617 | K190526 | 000 |
| 17290110204485 | K190526 | 000 |
| 17290110204478 | K190526 | 000 |
| 17290110204461 | K190526 | 000 |
| 17290110204454 | K190526 | 000 |
| 17290110204447 | K190526 | 000 |
| 17290110204430 | K190526 | 000 |
| 17290110204423 | K190526 | 000 |
| 17290110204416 | K190526 | 000 |
| 17290117350277 | K190526 | 000 |