FlareHawk Interbody Fusion System— 510(k) K243116

Name: FDA 510(k) clearance K243116
Creator: U.S. Food and Drug Administration
Published: 2025-05-21

Substantially Equivalent

Integrity Implants Inc. Dba Accelus

FDA 510(k) clearance K243116 for FlareHawk Interbody Fusion System, Substantially Equivalent on 2025-05-21. Applicant: Integrity Implants Inc. Dba Accelus. Device class: 2.

Clearance details

Applicant: Integrity Implants Inc. Dba Accelus
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2024-09-30
Decision date: 2025-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

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K261049 — SCALA® TL2026-08-20
K261430 — TruLift Expandable System2026-07-28
K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.