Spinal Alignment Solutions Pelvic Incidence (PI) Rod System (K242350)
Description
Spinal Alignment Solutions Pelvic Incidence (PI) Rod System by Spinal Alignment Solutions, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242350
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. Spinal Alignment Solutions Pelvic Incidence (PI) Rod System (K242350) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221646 | CD HORIZON ASTUTE SPINAL SYSTEM; CD HORIZON Growth Rod C... | Medtronic Sofamor Danek USA, Inc. | 2022 |
| K202771 | CD Horizon Spinal System | Medtronic | 2020 |
| K113174 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2011 |
Trace the full predicate network for K242350
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.