SIRION Lateral Lumbar Interbody System
FDA 510(k) K223335 · Astura Medical
510(k) numberK223335
Submission
- Device name
- SIRION Lateral Lumbar Interbody System
- Applicant
- Astura Medical
Irving, TX, US - Received
- November 1, 2022
- Decision date
- May 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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| 510(k) | Device | Decision |
|---|---|---|
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemPML · Traditional | 01/22/2026SE |
| 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 |
| K222097 | OLYMPIC Deformity Band SystemOWI · Traditional | 05/04/2023SE |
| K222554 | EL CAPITAN Anterior Lumbar Interbody FusionOVD · Traditional | 01/19/2023SE |
| K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion SystemOVD · Traditional | 03/30/2022SE |
Questions and answers
When was SIRION Lateral Lumbar Interbody System cleared by the FDA?
SIRION Lateral Lumbar Interbody System (K223335) received a 510(k) decision of Substantially Equivalent on May 9, 2023, 189 days after the submission was received.
What is the product code of K223335?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.