# Donson Machine Company (contract manufacturer, Alsip, IL): 13 new FDA device listings, incl. system, image processing, radiological

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Donson Machine Company |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Alsip, IL, US |
| New listings | 13 |
| Devices | System, Image Processing, Radiological; Orthopedic Stereotaxic Instrument; Spinal Vertebral Body Replacement Device - Cervical; Spinal Vertebral Body Replacement Device; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Intervertebral Fusion Device With Bone Graft, Lumbar |
| Product codes | LLZ, OLO, PLR, MQP, KWS, PHX, KWT, HSD, MBF, MAX, HWE, HXC |
| Device classes | Class I, Class II |
| Medical specialties | Radiology, Neurology, Orthopedic, General, Plastic Surgery |
| Brand names | ROSA Shoulder System; Ascend; HUM REF FOOT 125 DEG MEDIUM; HUM REF FOOT 135 DEG MEDIUM; HUM REF FOOT 125 DEG SMALL; RASP HANDLE; HUM REF FOOT 135 DEG LARGE; HUM REF FOOT 125 DEG LARGE |
| First new listing | 2026-05-26 |
| Latest new listing | 2026-08-11 |
| FDA registration number | 3004153896 |
| 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: 2026-11-04T21:52:36.524Z.
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.