Data / Medical devices / United States / Colorado Therapeutics LLC
Colorado Therapeutics LLC: FDA-registered device maker in Louisville, CO, United States, 1 510(k) clearance
Colorado Therapeutics LLC is registered with the FDA (registration 3012547639) in Louisville, CO, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 25, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012547639
- Address
- 486 South Pierce Avenue Suite A, Louisville, CO, United States, 80027
- Owner or operator
- Colorado Therapeutics LLC (10053864)
- Roles
- Manufacturer
- First device listed
- January 18, 2019
- Registered through
- 2026
- Brand names listed
- XIS+
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical | FTM | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Large Abdominal Wall Defects | OXK | 2 | 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 |
|---|---|---|---|---|---|---|
| October 25, 2017 | K172937 | Colorado Therapeutics Xenograft Implant | FTM | Substantially Equivalent | Colorado Therapeutics, LLC | accessdata.fda.gov |
Compare with other makers
Updated October 25, 2017. 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.