The following data is part of a premarket notification filed by Integrity Implants Inc with the FDA for Toro-l Interbody Fusion System.
| Device ID | K203038 |
| 510k Number | K203038 |
| Device Name: | Toro-L Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Integrity Implants Inc 354 Hiatt Drive Palm Beach Gardens, FL 33418 |
| Contact | Lauren Kamer |
| Correspondent | Lauren Kamer Integrity Implants Inc 354 Hiatt Drive Palm Beach Gardens, FL 33418 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-06 |
| Decision Date | 2021-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840200408608 | K203038 | 000 |
| 00084020040857 | K203038 | 000 |
| 00810004729612 | K203038 | 000 |
| 00810004729629 | K203038 | 000 |
| 00810004729636 | K203038 | 000 |
| 00810004729643 | K203038 | 000 |
| 00810004729650 | K203038 | 000 |
| 00840200408585 | K203038 | 000 |
| 00840200408592 | K203038 | 000 |
| 00840200408578 | K203038 | 000 |