FlareHawk Interbody Fusion System
FDA 510(k) K243116 · Integrity Implants Inc. Dba Accelus
510(k) numberK243116
Submission
- Device name
- FlareHawk Interbody Fusion System
- Applicant
- Integrity Implants Inc. Dba Accelus
Palm Beach Gardens, FL, US - Received
- September 30, 2024
- Decision date
- May 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code MAX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
Questions and answers
When was FlareHawk Interbody Fusion System cleared by the FDA?
FlareHawk Interbody Fusion System (K243116) received a 510(k) decision of Substantially Equivalent on May 21, 2025, 233 days after the submission was received.
What is the product code of K243116?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.