K252546
- 510(k) number
- K252546
- Device name
- VantageTM Lumbar Decompression Kit
- Applicant
- Allevion Medical, LLC FL · US
- Product code
- HRX — Arthroscope
- Decision date
- 2026-03-12
- Date received
- 2025-08-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K252546.pdf
Official FDA record: K252546
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.