Class Class II
SIRION Lateral Lumbar Interbody System (K223335)
Description
SIRION Lateral Lumbar Interbody System by Astura Medical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223335
Clearance Date2023-05-09
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223335
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SIRION Lateral Lumbar Interbody System (K223335) cites 8 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211740 | DualX | Amplify Surgical, Inc. | 2021 |
| K210061 | ProLift Lateral HELO Fixated | Life Spine, Inc. | 2021 |
| K192006 | SIRION Lateral Lumbar Interbody System | Astura Medical, LLC | 2020 |
| K182877 | HALF DOME Posterior Lumbar Interbody System | Astura Medical, LLC | 2019 |
| K152512 | Half Dome Posterior Lumbar Interbody System | Astura Medical | 2016 |
| K113447 | RISE SPACER | Globus Medical, Inc. | 2012 |
| K081968 | MODIFICATION TO LUCENT | Spinal Elements, Inc. | 2008 |
| K071724 | LUCENT | Spinal Elements, Inc. | 2007 |
Trace the full predicate network for K223335
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.