Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System (K242147)
Description
Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System by Alphatec Spine, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242147
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. Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System (K242147) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 |
| K222028 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec In... | Alphatec Spine | 2022 |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent ... | Nu Vasive, Incorporated | 2021 |
| K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbo... | Alphatec Spine, Inc. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243461 | Calibrate Interbody Systems | Alphatec Spine, Inc. | 2025 |
Trace the full predicate network for K242147
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.