Class Class II
ProLift Pivot Expandable Spacer System (K243668)
Description
ProLift Pivot Expandable Spacer System by Life Spine, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243668
Clearance Date2025-01-23
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243668
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. ProLift Pivot Expandable Spacer System (K243668) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223430 | ProLift Micro Expandable Spacer System | Life Spine, Inc. | 2023 |
| K212520 | ProLift Micro Expandable Spacer System | Life Spine, Inc. | 2021 |
| K202298 | Lucent XP, Lucent XP Curved | Spinal Elements, Inc. | 2020 |
| K193521 | Steerable Plateau Ti | Life Spine, Inc. | 2020 |
| K190488 | ProLift Expandable System | Life Spine, Inc. | 2019 |
| K140411 | ALTERA SPACER | Globus Medical, Inc. | 2014 |
Trace the full predicate network for K243668
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.