Stabilis SA Cervical Stand-Alone System (Various PNs) (K251735)
Description
Stabilis SA Cervical Stand-Alone System (Various PNs) by Acuity Surgical Devices, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251735
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. Stabilis SA Cervical Stand-Alone System (Various PNs) (K251735) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230639 | Align Cervical Interbody Fusion System | Acuity Surgical Devices, LLC | 2023 |
| K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | 2022 |
| K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Nexxt Spine, LLC | 2020 |
| K111272 | RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM | Rhausler, Inc. | 2011 |
Trace the full predicate network for K251735
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.