The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for Carboclear Navigated Instruments.
| Device ID | K201251 |
| 510k Number | K201251 |
| Device Name: | CarboClear Navigated Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-11 |
| Decision Date | 2020-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110208516 | K201251 | 000 |
| 07290110208417 | K201251 | 000 |
| 07290110208448 | K201251 | 000 |
| 07290110208455 | K201251 | 000 |
| 07290110208462 | K201251 | 000 |
| 07290110208479 | K201251 | 000 |
| 07290110208486 | K201251 | 000 |
| 07290110208493 | K201251 | 000 |
| 07290110208509 | K201251 | 000 |
| 07290110208400 | K201251 | 000 |