The following data is part of a premarket notification filed by Carlsmed, Inc. with the FDA for Aprevo Transforaminal Ibf.
| Device ID | K210542 |
| 510k Number | K210542 |
| Device Name: | Aprevo Transforaminal IBF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Carlsmed, Inc. 4250 Executive Sq., Ste. 675 La Jolla, CA 92037 |
| Contact | Karen Liu |
| Correspondent | Karen Liu Carlsmed, Inc. 4250 Executive Sq., Ste. 675 La Jolla, CA 92037 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-24 |
| Decision Date | 2021-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810056990862 | K210542 | 000 |
| 00810056990541 | K210542 | 000 |
| 00810056990534 | K210542 | 000 |
| 00810056990497 | K210542 | 000 |
| 00810056990480 | K210542 | 000 |
| 00810056990442 | K210542 | 000 |
| 00810056990435 | K210542 | 000 |
| 00810056990398 | K210542 | 000 |
| 00810056990381 | K210542 | 000 |
| 00810056990343 | K210542 | 000 |
| 00810056990336 | K210542 | 000 |
| 00810056990299 | K210542 | 000 |
| 00810056990282 | K210542 | 000 |
| 00810056990244 | K210542 | 000 |
| 00810056990589 | K210542 | 000 |
| 00810056990596 | K210542 | 000 |
| 00810056990855 | K210542 | 000 |
| 00810056990848 | K210542 | 000 |
| 00810056990831 | K210542 | 000 |
| 00810056990824 | K210542 | 000 |
| 00810056990817 | K210542 | 000 |
| 00810056990800 | K210542 | 000 |
| 00810056990794 | K210542 | 000 |
| 00810056990787 | K210542 | 000 |
| 00810056990770 | K210542 | 000 |
| 00810056990763 | K210542 | 000 |
| 00810056990688 | K210542 | 000 |
| 00810056990640 | K210542 | 000 |
| 00810056990633 | K210542 | 000 |
| 00810056990237 | K210542 | 000 |