The following data is part of a premarket notification filed by Integrity Implants Inc. with the FDA for Flarehawk Interbody Fusion System.
| Device ID | K202198 |
| 510k Number | K202198 |
| 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 | 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 | 2020-08-05 |
| Decision Date | 2020-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810045530949 | K202198 | 000 |
| 00810045530444 | K202198 | 000 |
| 00810045530437 | K202198 | 000 |
| 00810045530420 | K202198 | 000 |
| 00810004729964 | K202198 | 000 |
| 00810004729957 | K202198 | 000 |
| 00810004729940 | K202198 | 000 |
| 00810004729933 | K202198 | 000 |
| 00810004729926 | K202198 | 000 |
| 00810004729919 | K202198 | 000 |
| 00818613021400 | K202198 | 000 |
| 00818613021394 | K202198 | 000 |
| 00818613021387 | K202198 | 000 |
| 00818613021370 | K202198 | 000 |
| 00818613021363 | K202198 | 000 |
| 00810045530451 | K202198 | 000 |
| 00810045530468 | K202198 | 000 |
| 00810045530932 | K202198 | 000 |
| 00810045530925 | K202198 | 000 |
| 00810045530918 | K202198 | 000 |
| 00810045530901 | K202198 | 000 |
| 00810045530895 | K202198 | 000 |
| 00810045530550 | K202198 | 000 |
| 00810045530543 | K202198 | 000 |
| 00810045530536 | K202198 | 000 |
| 00810045530529 | K202198 | 000 |
| 00810045530512 | K202198 | 000 |
| 00810045530505 | K202198 | 000 |
| 00810045530499 | K202198 | 000 |
| 00810045530482 | K202198 | 000 |
| 00810045530475 | K202198 | 000 |
| 00818613021356 | K202198 | 000 |