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510(k) K192492

EL CAPITAN Anterior Lumber Interbody System by Astura Medical, LLC — Product Code OVD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2020
Date Received
September 11, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

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  • 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)

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  • K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
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  • K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)