# Millstone Medical Outsourcing LLC. (contract manufacturer, Fall River, MA): 24 new FDA device listings, incl. peripheral blood processing device for wound management

**Score:** 90/100

| Field | Value |
|---|---|
| Establishment | Millstone Medical Outsourcing LLC. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Fall River, MA, US |
| New listings | 24 |
| Devices | Peripheral Blood Processing Device For Wound Management; Thoracolumbosacral Pedicle Screw System; Needle, Suturing, Disposable; Orthopedic Augmented Reality; Orthopedic Stereotaxic Instrument; Intervertebral Fusion Device With Bone Graft, Cervical; Shoulder Prosthesis, Reverse Configuration; Intervertebral Fusion Device With Bone Graft, Thoracic; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Lumbar |
| Product codes | PMQ, NKB, GAB, SBF, OLO, ODP, PHX, PHM, OVD, MAX, JWH, OVE |
| Device classes | Class I, Class II |
| Medical specialties | Hematology, Orthopedic, General, Plastic Surgery, Neurology |
| Brand names | ROSA® Shoulder System |
| First new listing | 2026-05-29 |
| Latest new listing | 2026-10-08 |
| FDA registration number | 1226544 |
| Registration expires | 2027-12-31 |

## 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.
- 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.