K-number	K253748
Device name	Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System
Applicant	Life Spine, Inc.
Product code	MAX
Device class	Class II
Decision date	Jan 23, 2026
Decision	Substantially Equivalent
Regulation	888.3080

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System are intervertebral body fusion devices intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease at one or two contiguous levels (L2-S1). The devices are expandable titanium spacers filled with bone graft that work with supplemental fixation systems to restore disc height and promote spinal fusion.

Technological characteristics

The devices are fabricated from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, available in multiple sizes and footprints, expandable from 8mm to 26mm in height, with superior and inferior tooth surfaces to prevent rotation and migration. The ProLift Lateral Fixated variant includes integrated screws in 5.5mm and 6.5mm diameters with 25-60mm lengths. All implants are single-use only.

Test standards cited

ASTM F136 (titanium alloy material specification) and ASTM F2182 (MRI compatibility testing, with the product meeting MRI Conditional status).

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System

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