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510(k) K202495

SIRION Lateral Lumbar Interbody Fusion by Astura Medical, LLC — Product Code MAX

K202495 is an FDA 510(k) premarket notification submitted by Astura Medical, LLC for the device "SIRION Lateral Lumbar Interbody Fusion". The FDA issued a decision of Substantially Equivalent on January 6, 2021. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Astura Medical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2021
Date Received
August 31, 2020
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.

Other clearances by Astura Medical, LLC

  • K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (January 22, 2026)
  • K252346 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (October 21, 2025)
  • K243259 — MASADA Modular Spinal Fixation System (January 7, 2025)
  • K240160 — EGPS Navigated Instruments (October 17, 2024)
  • K233359 — DOMINION Expandable Corpectomy System (March 8, 2024)
  • K231694 — MASADA Modular Spinal Fixation System (November 16, 2023)
  • K232211 — REUNION Sacroiliac Joint Fusion System (October 24, 2023)
  • K223335 — SIRION Lateral Lumbar Interbody System (May 9, 2023)
  • K222097 — OLYMPIC Deformity Band System (May 4, 2023)
  • K222554 — EL CAPITAN Anterior Lumbar Interbody Fusion (January 19, 2023)

Other clearances for product code MAX

  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources