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510(k) K243116

FlareHawk Interbody Fusion System by Integrity Implants Inc. Dba Accelus — Product Code MAX

K243116 is an FDA 510(k) premarket notification submitted by Integrity Implants Inc. Dba Accelus for the device "FlareHawk Interbody Fusion System". The FDA issued a decision of Substantially Equivalent on May 21, 2025. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)
  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K253583 — LUX Expandable Lumbar Interbody System (February 23, 2026)
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FDA data resources