Montross Extremity Medical Hemi Implant System— 510(k) K221220

Substantially Equivalent

Montross Extremity Medical

FDA 510(k) clearance K221220 for Montross Extremity Medical Hemi Implant System, Substantially Equivalent on 2023-04-19. Applicant: Montross Extremity Medical.

Clearance details

Applicant
Montross Extremity Medical
Product code
Code KWD
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Colorado Springs, CO, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KWD

product code KWD
Injury
164
Total
164

Source: openFDA MAUDE database, through . 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.