Tera Lumbar Interbody Fusion System (Various PNs) (K251335)
Description
Tera Lumbar Interbody Fusion 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 K251335
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. Tera Lumbar Interbody Fusion System (Various PNs) (K251335) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | 2025 |
| K222561 | Align | Acuity Surgical Devices, LLC | 2022 |
| K221535 | Align Lumbar Interbody Fusion System | Acuity Surgical Devices, LLC | 2022 |
Trace the full predicate network for K251335
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.