The following data is part of a premarket notification filed by Integrity Implants Inc. with the FDA for Flarehawk Interbody Fusion System.
| Device ID | K220453 |
| 510k Number | K220453 |
| Device Name: | FlareHawk Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Integrity Implants Inc. 354 Hiatt Drive Palm Beach Gardens, FL 33418 |
| Contact | Anne Mulvihill |
| Correspondent | Anne Mulvihill Integrity Implants Inc. 354 Hiatt Drive Palm Beach Gardens, FL 33418 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-17 |
| Decision Date | 2022-03-24 |