Class Class II
SPIRA® Anterior Lumbar Spacers (K234077)
Description
SPIRA® Anterior Lumbar Spacers by Camber Spine Technologies, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK234077
Clearance Date2024-07-12
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234077
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. SPIRA® Anterior Lumbar Spacers (K234077) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expan... | Globus Medical, Inc. | 2022 |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMEN... | Globus Medical, Inc. | 2021 |
| K201087 | CORBEL Spacers | Globus Medical, Inc. | 2020 |
| K200002 | Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbo... | 4Web, Inc. | 2020 |
| K190483 | SPIRA Open Matrix ALIF and LLIF | Camber Spine Technologies | 2019 |
| K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 |
| K162986 | SPIRA Open Matrix ALIF | Camber Spine Technologies | 2017 |
Trace the full predicate network for K234077
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.