K-number	K251969
Device name	Atlas Spine Project X Expandable Posterior Lumbar Interbody System
Applicant	Atlas Spine, Inc.
Product code	MAX
Device class	Class II
Decision date	Aug 15, 2025
Decision	Substantially Equivalent
Regulation	888.3080

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Atlas Spine Project X Expandable Posterior Lumbar Interbody System is an intervertebral body fusion device intended for patients with degenerative disc disease at one or two contiguous lumbar levels (L2-S1) who have failed at least six months of conservative treatment. The device is filled with autogenous bone graft material and used with supplemental fixation such as the Apelo Pedicle Screw System.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Atlas Spine Project X Expandable Posterior Lumbar Interbody System

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