Data / Medical devices / United States / COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen
COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen: FDA-registered device maker in Eden Prairie, MN, United States, 1 510(k) clearance
COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen is registered with the FDA (registration 3014003617) in Eden Prairie, MN, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 16, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014003617
- Address
- 6455 City West Pkwy #100, Eden Prairie, MN, United States, 55344
- Owner or operator
- RTI Surgical, Inc. (dba RTI Biologics, Inc.) (1641375)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- July 17, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Animal Source | NPM | 2 | Specification developer | accessdata.fda.gov |
| Mesh, Surgical | FTM | 2 | Contract manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 16, 2024 | K240133 | Xenograft Bovine Bone Particulate | NPM | Substantially Equivalent | Collagen Solutions, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Bone Grafting Material, Animal Source
- All makers of Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- All makers of Mesh, Surgical
Updated August 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.