RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (K251154)
Description
RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments by Ht Medical D.B.A. Xenix Medical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251154
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. RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (K251154) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | 2025 |
| K212692 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2021 |
| K140454 | NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS | Medtronic Sofamor Danek USA, Inc. | 2014 |
| K112759 | APCLO PEDICLE SCREW SYSTEMS | Atlas Spine, Inc. | 2011 |
Trace the full predicate network for K251154
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.