Class Class II
COSINE™ Spacer (K234035)
Description
COSINE™ Spacer by Globus Medical, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK234035
Clearance Date2024-09-06
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234035
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. COSINE™ Spacer (K234035) cites 9 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications... | Globus Medical, Inc. | 2023 |
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expan... | Globus Medical, Inc. | 2022 |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF... | Nu Vasive, Incorporated | 2022 |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent ... | Nu Vasive, Incorporated | 2021 |
| K210439 | NuVasive MOD-EX XLIF Interbody System | Nu Vasive, Incorporated | 2021 |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMEN... | Globus Medical, Inc. | 2021 |
| K192115 | SABLE Expandable Spacer | Globus Medical, Inc. | 2020 |
| K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 |
| K113447 | RISE SPACER | Globus Medical, Inc. | 2012 |
Trace the full predicate network for K234035
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.