# Surgentec LLC (manufacturer, Boca Raton, FL): 15 new FDA device listings, incl. system, facet screw spinal device

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | Surgentec LLC |
| Owner / operator | SurGenTec LLC |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Boca Raton, FL, US |
| New listings | 15 |
| Devices | System, Facet Screw Spinal Device; Orthopedic Stereotaxic Instrument; Sacroiliac Joint Fixation; Rongeur, Manual; Arthroscope; Cover, Barrier, Protective; Drape, Surgical, Antimicrobial; Ring (Wound Protector), Drape Retention, Internal; Retractor, Self-Retaining, For Neurosurgery; Syringe, Piston |
| Product codes | MRW, OLO, OUR, HAE, HRX, MMP, KKX, KGW, GZT, FMF |
| Device classes | Class II, Unclassified |
| Medical specialties | Neurology, Orthopedic, General, Plastic Surgery, General Hospital |
| Brand names | ION-L; TiLink- L Navigation; Tilink-L Helix; Vantage Lumbar Decompression Kit; DuraShield Device Kit; ION-C Navigation; ION-L Navigated Instruments; Kit with Direct Cannula Access and Visualization for Decompression |
| First new listing | 2026-05-13 |
| Latest new listing | 2026-10-16 |
| FDA registration number | 3012495575 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.