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 | K213355 |
| 510k Number | K213355 |
| 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 | Alexa Kamer |
| Correspondent | Alexa 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 | 2021-10-12 |
| Decision Date | 2022-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840200409162 | K213355 | 000 |
| 00840200404037 | K213355 | 000 |
| 00810045539003 | K213355 | 000 |
| 00810004729605 | K213355 | 000 |
| 00810004729599 | K213355 | 000 |
| 00810004729582 | K213355 | 000 |
| 00810004729575 | K213355 | 000 |
| 00840200403016 | K213355 | 000 |
| 00840200403009 | K213355 | 000 |
| 00840200402996 | K213355 | 000 |
| 00840200404464 | K213355 | 000 |
| 00840200404594 | K213355 | 000 |
| 00840200409155 | K213355 | 000 |
| 00840200409148 | K213355 | 000 |
| 00840200409131 | K213355 | 000 |
| 00840200408684 | K213355 | 000 |
| 00840200404648 | K213355 | 000 |
| 00840200404631 | K213355 | 000 |
| 00840200404624 | K213355 | 000 |
| 00840200404617 | K213355 | 000 |
| 00840200404600 | K213355 | 000 |
| 00840200402989 | K213355 | 000 |