FDA 510(k)

FlareHawk Interbody Fusion System

K-Number: K243116 · 2025-05-21

ApplicantIntegrity Implants Inc. Dba Accelus

Decision Date2025-05-21

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FlareHawk Interbody Fusion System is a medical device manufactured by Integrity Implants Inc. Dba Accelus. It received FDA 510(k) clearance on 2025-05-21 under approval number K243116. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlareHawk Interbody Fusion System?

FlareHawk Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Integrity Implants Inc. Dba Accelus. The 510(k) number is K243116.

When was FlareHawk Interbody Fusion System approved by the FDA?

FlareHawk Interbody Fusion System received FDA 510(k) clearance on 2025-05-21, under approval number K243116.

What company makes FlareHawk Interbody Fusion System?

FlareHawk Interbody Fusion System is manufactured by Integrity Implants Inc. Dba Accelus.

What is the FDA product code for FlareHawk Interbody Fusion System?

The FDA product code for FlareHawk Interbody Fusion System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.