# Spinecraft LLC (manufacturer, Westmont, IL): 4 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Spinecraft LLC |
| Role | Manufacturer |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | Westmont, IL, US |
| New listings | 4 |
| Devices | Intervertebral Fusion Device With Bone Graft, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Cervical; Appliance, Fixation, Spinal Intervertebral Body |
| Product codes | MAX, OVD, ODP, KWQ |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | ORIO-3D Cage System; ANTERIS Thoracolumbar Plate System |
| First new listing | 2026-05-12 |
| Latest new listing | 2026-05-12 |
| FDA registration number | 3004717358 |
| Registration expires | 2026-12-31 |

## 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.

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.