The following data is part of a premarket notification filed by Integrity Implants Inc with the FDA for Flarehawk Interbody Fusion System.
| Device ID | K183184 |
| 510k Number | K183184 |
| Device Name: | FlareHawk Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Integrity Implants Inc 850 Parkway Street Jupiter, FL 33477 |
| Contact | Lauren Kamer |
| Correspondent | Lauren Kamer Integrity Implants Inc 850 Parkway Street Jupiter, FL 33477 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810004722255 | K183184 | 000 |
| 00810004721579 | K183184 | 000 |
| 00810004721562 | K183184 | 000 |
| 00810004721555 | K183184 | 000 |
| 00810004721548 | K183184 | 000 |
| 00810004721463 | K183184 | 000 |
| 00810004721456 | K183184 | 000 |
| 00810004721432 | K183184 | 000 |
| 00810004721425 | K183184 | 000 |
| 00810004728431 | K183184 | 000 |
| 00810004721586 | K183184 | 000 |
| 00810004721593 | K183184 | 000 |
| 00810004722248 | K183184 | 000 |
| 00810004721838 | K183184 | 000 |
| 00810004721814 | K183184 | 000 |
| 00810004721654 | K183184 | 000 |
| 00810004721647 | K183184 | 000 |
| 00810004721630 | K183184 | 000 |
| 00810004721623 | K183184 | 000 |
| 00810004721616 | K183184 | 000 |
| 00810004721609 | K183184 | 000 |
| 00810004722286 | K183184 | 000 |