SIRION Lateral Lumbar Interbody Fusion— 510(k) K202495

Name: FDA 510(k) clearance K202495
Creator: U.S. Food and Drug Administration
Published: 2021-01-06

Substantially Equivalent

Astura Medical, LLC

FDA 510(k) clearance K202495 for SIRION Lateral Lumbar Interbody Fusion, Substantially Equivalent on 2021-01-06. Applicant: Astura Medical, LLC. Device class: 2.

Clearance details

Applicant: Astura Medical, LLC
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2020-08-31
Decision date: 2021-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

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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

More clearances from Astura Medical, LLC

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K202065 — DOLOMITE Anterior Cervical Stabilization System2020-10-26
K192492 — EL CAPITAN Anterior Lumber Interbody System2020-04-21
K192006 — SIRION Lateral Lumbar Interbody System2020-04-02
K190426 — ALTA Anterior Cervical Corpectomy System2019-10-24
K182877 — HALF DOME Posterior Lumbar Interbody System2019-05-03

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.