Class Class II
JAZZ Spinal System (K252437)
Description
JAZZ Spinal System by Implanet, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK252437
Clearance Date2025-08-28
Clearance TypeSpecial
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252437
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. JAZZ Spinal System (K252437) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240392 | JAZZ Spinal System | Implanet | 2024 |
| K230961 | Zeus Spinal System | Shanghai Sanyou Medical Co, Ltd. | 2023 |
Trace the full predicate network for K252437
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.