# Empirical Spine, Inc. (manufacturer, Morgan Hill, CA): 2 new FDA device listings, incl. manual instruments designed for use with non-fusion spinous process te

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Empirical Spine, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Morgan Hill, CA, US |
| New listings | 2 |
| Devices | Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Product codes | SGL, KCT |
| Device classes | Class II |
| Medical specialties | Orthopedic, General Hospital |
| Brand names | Instrument Tray; Tensioner; Holder; Tensioner Clip; Driver; Symbol Plate; Passer |
| First new listing | 2026-07-17 |
| Latest new listing | 2026-07-17 |
| FDA registration number | 3013114075 |
| 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.
- 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.