# Spine Wave, Inc. (manufacturer, Shelton, CT): 6 new FDA device listings, incl. bit, drill

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Spine Wave, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Shelton, CT, US |
| New listings | 6 |
| Devices | Bit, Drill; Gauge, Depth; Guide, Surgical, Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Bone Cement, Posterior Screw Augmentation; Thoracolumbosacral Pedicle Screw System |
| Product codes | HTW, HTJ, FZX, MAX, PML, NKB |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, General, Plastic Surgery |
| Brand names | Drill; Depth Gauge; Drill Guide; Exceed® Plus Biplanar Expandable Interbody System; Salvo® Spine System |
| First new listing | 2026-07-20 |
| Latest new listing | 2026-08-31 |
| FDA registration number | 3004638600 |
| 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.