# Centinel Spine, LLC (specification developer, West Chester, PA): 2 new FDA device listings, incl. manual instruments designed for use with total disc replacement device

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Centinel Spine, LLC |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | West Chester, PA, US |
| New listings | 2 |
| Devices | Manual Instruments Designed For Use With Total Disc Replacement Devices; Bit, Surgical |
| Product codes | QLQ, GFG |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, General, Plastic Surgery |
| Brand names | prodisc® L Instruments - Hemi chisel; prodisc® L Instruments - Impactors; prodisc c milling bits |
| First new listing | 2026-09-23 |
| Latest new listing | 2026-10-06 |
| FDA registration number | 3007494564 |
| 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.
- 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.