K243191
- 510(k) number
- K243191
- Device name
- Atlas Spine Lateral Expandable Interbody System
- Applicant
- Atlas Spine, Inc. FL · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2024-11-26
- Date received
- 2024-09-30
- 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: K243191
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.