COLORADO THERAPEUTICS XENOGRAFT IMPLANT— 510(k) K160181

Substantially Equivalent

Colorado Therapeutics, LLC

FDA 510(k) clearance K160181 for COLORADO THERAPEUTICS XENOGRAFT IMPLANT, Substantially Equivalent on 2016-10-20. Applicant: Colorado Therapeutics, LLC.

Clearance details

Applicant: Colorado Therapeutics, LLC
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2016-01-27
Decision date: 2016-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomfield, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.