K251969
- 510(k) number
- K251969
- Device name
- Atlas Spine Project X Expandable Posterior Lumbar Interbody System
- Applicant
- Atlas Spine, Inc. FL · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-08-15
- Date received
- 2025-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K251969
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.