EL CAPITAN Anterior Lumber Interbody System
FDA 510(k) K192492 · Astura Medical, LLC
510(k) numberK192492
Submission
- Device name
- EL CAPITAN Anterior Lumber Interbody System
- Applicant
- Astura Medical, LLC
Carlsbad, CA, US - Received
- September 11, 2019
- Decision date
- April 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
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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|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
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| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
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| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemNKB · Traditional | 10/21/2025SE |
| K243259 | MASADA Modular Spinal Fixation SystemNKB · Traditional | 01/07/2025SE |
| K240160 | EGPS Navigated InstrumentsOLO · Traditional | 10/17/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | 03/08/2024SE |
| K231694 | MASADA Modular Spinal Fixation SystemNKB · Traditional | 11/16/2023SE |
| K232211 | REUNION Sacroiliac Joint Fusion SystemOUR · Traditional | 10/24/2023SE |
| K223335 | SIRION Lateral Lumbar Interbody SystemMAX · Traditional | 05/09/2023SE |
| K222097 | OLYMPIC Deformity Band SystemOWI · Traditional | 05/04/2023SE |
| K222554 | EL CAPITAN Anterior Lumbar Interbody FusionOVD · Traditional | 01/19/2023SE |
Questions and answers
When was EL CAPITAN Anterior Lumber Interbody System cleared by the FDA?
EL CAPITAN Anterior Lumber Interbody System (K192492) received a 510(k) decision of Substantially Equivalent on April 21, 2020, 223 days after the submission was received.
What is the product code of K192492?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.