# Vantage Lumbar Decompression Kit (K263208): 510(k) cleared for SurGenTec, LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 41/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263208 |
| Device | Vantage Lumbar Decompression Kit |
| Applicant | SurGenTec, LLC |
| Specialty / panel | Orthopedic |
| Product code | HRX |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-14 |
| Decision date | 2026-10-14 |
| Review time (days) | 30 |
| Third-party review | No |
| Applicant location | Boca Raton, FL, US |

## Why this score
- Fast 30-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 21 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263208). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.