DeviceClearance

K091763

Substantially Equivalent

MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000

Applicant
Instratek, Inc.
Product code
HTN
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Spring, TX, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HTN

product code HTN
Injury
310
Malfunction
639
Total
949

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.