# Elite Medical, LLC (contract manufacturer, Florence, AL): 17 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Elite Medical, LLC |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Florence, AL, US |
| New listings | 17 |
| Devices | Intervertebral Fusion Device With Bone Graft, Lumbar; Instrument, Cutting, Orthopedic; Curette; Appliance, Fixation, Spinal Interlaminal; Intervertebral Fusion Device With Bone Graft, Cervical; Elevator; Mallet; Intervertebral Fusion Device With Bone Graft, Thoracic; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Product codes | MAX, HTZ, HTF, KWP, ODP, HTE, HXL, PHM, OVD, OVE, GFI, KWQ |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, General, Plastic Surgery |
| First new listing | 2026-08-28 |
| Latest new listing | 2026-09-03 |
| FDA registration number | 3017565094 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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.