Class Class II
FlareHawk Interbody Fusion System (K243116)
Description
FlareHawk Interbody Fusion System by Integrity Implants Inc. Dba Accelus, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243116
Clearance Date2025-05-21
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243116
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. FlareHawk Interbody Fusion System (K243116) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220453 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2022 |
| K202198 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2020 |
Trace the full predicate network for K243116
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.