Class Class II
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (K253876)
Description
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) by Globus Medical, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK253876
Clearance Date2025-12-22
Clearance TypeSpecial
Product CodeOVE
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K253876
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. HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (K253876) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | 2026 |
Trace the full predicate network for K253876
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.