The following data is part of a premarket notification filed by Vy Spine, Llc with the FDA for Lumivy Lumbar Ibf System.
| Device ID | K212930 |
| 510k Number | K212930 |
| Device Name: | LumiVy Lumbar IBF System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 |
| Contact | Jordan Hendrickson |
| Correspondent | Jordan Hendrickson Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 |
| Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-14 |
| Decision Date | 2022-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840283402487 | K212930 | 000 |
| 00840283402395 | K212930 | 000 |
| 00840283402388 | K212930 | 000 |
| 00840283402371 | K212930 | 000 |
| 00840283402364 | K212930 | 000 |
| 00840283402418 | K212930 | 000 |
| 00840283402401 | K212930 | 000 |
| 00840283402456 | K212930 | 000 |
| 00840283402449 | K212930 | 000 |
| 00840283402432 | K212930 | 000 |
| 00840283402463 | K212930 | 000 |
| 00840283402517 | K212930 | 000 |
| 00840283402470 | K212930 | 000 |
| 00840283404443 | K212930 | 000 |
| 00840283402500 | K212930 | 000 |
| 00840283402494 | K212930 | 000 |
| 00840283402562 | K212930 | 000 |
| 00840283402555 | K212930 | 000 |
| 00840283402548 | K212930 | 000 |
| 00840283402531 | K212930 | 000 |
| 00840283402524 | K212930 | 000 |
| 00840283402425 | K212930 | 000 |