The following data is part of a premarket notification filed by Curiteva, Inc. with the FDA for Curiteva Sacroiliac Joint Fusion System.
| Device ID | K210402 |
| 510k Number | K210402 |
| Device Name: | Curiteva Sacroiliac Joint Fusion System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Curiteva, Inc. 25127 Will McComb Drive Tanner, AL 35671 |
| Contact | Eric Linder |
| Correspondent | Eric Linder Curiteva, Inc. 25127 Will McComb Drive Tanner, AL 35671 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-10 |
| Decision Date | 2021-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B648C6141230H0 | K210402 | 000 |
| B648C6147065H0 | K210402 | 000 |
| B648C6147070H0 | K210402 | 000 |
| B648C6149530H0 | K210402 | 000 |
| B648C6149535H0 | K210402 | 000 |
| B648C6149540H0 | K210402 | 000 |
| B648C6149545H0 | K210402 | 000 |
| B648C6149550H0 | K210402 | 000 |
| B648C6149555H0 | K210402 | 000 |
| B648C6149560H0 | K210402 | 000 |
| B648C6149565H0 | K210402 | 000 |
| B648C6149570H0 | K210402 | 000 |
| B648C61412300 | K210402 | 000 |
| B648C61412350 | K210402 | 000 |
| B648C6147060H0 | K210402 | 000 |
| B648C6147055H0 | K210402 | 000 |
| B648C6141235H0 | K210402 | 000 |
| B648C6141240H0 | K210402 | 000 |
| B648C6141245H0 | K210402 | 000 |
| B648C6141250H0 | K210402 | 000 |
| B648C6141255H0 | K210402 | 000 |
| B648C6141260H0 | K210402 | 000 |
| B648C6141265H0 | K210402 | 000 |
| B648C6141270H0 | K210402 | 000 |
| B648C6147030H0 | K210402 | 000 |
| B648C6147035H0 | K210402 | 000 |
| B648C6147040H0 | K210402 | 000 |
| B648C6147045H0 | K210402 | 000 |
| B648C6147050H0 | K210402 | 000 |
| B648C61412400 | K210402 | 000 |
| B648C61412450 | K210402 | 000 |
| B648C61470700 | K210402 | 000 |
| B648C61470KC0 | K210402 | 000 |
| B648C61470SC0 | K210402 | 000 |
| B648C61495300 | K210402 | 000 |
| B648C61495350 | K210402 | 000 |
| B648C61495400 | K210402 | 000 |
| B648C61495450 | K210402 | 000 |
| B648C61495500 | K210402 | 000 |
| B648C61495550 | K210402 | 000 |
| B648C61495600 | K210402 | 000 |
| B648C61495650 | K210402 | 000 |
| B648C61495700 | K210402 | 000 |
| B648C61495KC0 | K210402 | 000 |
| B648C61470650 | K210402 | 000 |
| B648C61470600 | K210402 | 000 |
| B648C61412500 | K210402 | 000 |
| B648C61412550 | K210402 | 000 |
| B648C61412600 | K210402 | 000 |
| B648C61412650 | K210402 | 000 |
| B648C61412700 | K210402 | 000 |
| B648C61412KC0 | K210402 | 000 |
| B648C61412SC0 | K210402 | 000 |
| B648C61470300 | K210402 | 000 |
| B648C61470350 | K210402 | 000 |
| B648C61470400 | K210402 | 000 |
| B648C61470450 | K210402 | 000 |
| B648C61470500 | K210402 | 000 |
| B648C61470550 | K210402 | 000 |
| B648C61495SC0 | K210402 | 000 |