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510(k) K243116

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

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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