The following data is part of a premarket notification filed by Integrity Implants Inc. with the FDA for Flarehawk Tihawk9 Interbody Fusion System.
| Device ID | K201367 |
| 510k Number | K201367 |
| Device Name: | FlareHawk TiHawk9 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 | 2020-05-22 |
| Decision Date | 2020-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810004728202 | K201367 | 000 |
| 00810004728196 | K201367 | 000 |
| 00810004728189 | K201367 | 000 |
| 00810004728172 | K201367 | 000 |
| 00810004728165 | K201367 | 000 |
| 00810004728158 | K201367 | 000 |