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 |
|---|---|---|
| 03662663085700 | K183184 | 000 |
| 03662663096058 | K183184 | 000 |
| 03662663096072 | K183184 | 000 |
| 03662663096096 | K183184 | 000 |
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| 00810004722286 | K183184 | 000 |
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| 00810004721814 | K183184 | 000 |
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| 00810004721579 | K183184 | 000 |
| 00810004722255 | K183184 | 000 |