510(k) clearance
Vantage Lumbar Decompression Kit
- 510(k) number
- K263208
- Applicant
- SurGenTec, LLC
- Decision date
- Oct 14, 2026
- Date received
- Sep 14, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- HRX
- Device type
- Arthroscope
- Device class
- Class II
- Regulation
- 21 CFR 888.1100
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Boca Raton, FL, US