K242457
- 510(k) number
- K242457
- Device name
- EARP Interbody System
- Applicant
- Retropsoas Technologies, LLC MO · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-10-07
- Date received
- 2024-08-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K242457.pdf
Official FDA record: K242457
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.