# COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen (contract manufacturer, Eden Prairie, MN): 3 new FDA device listings, incl. mesh, surgical, collagen, orthopaedics, reinforcement of tendon

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen |
| Owner / operator | RTI Surgical, Inc. (dba RTI Biologics, Inc.) |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer); Develop Specifications But Do Not Manufacture At This Facility |
| Location | Eden Prairie, MN, US |
| New listings | 3 |
| Devices | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon; Mesh, Surgical; Bone Grafting Material, Animal Source |
| Product codes | OWY, FTM, NPM |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, Dental |
| First new listing | 2026-07-17 |
| Latest new listing | 2026-07-17 |
| FDA registration number | 3014003617 |
| 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.