DeviceClearance

K820995

Substantially Equivalent

MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS

Applicant
Ludek Optics, Inc.
Product code
KRO
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KRO

product code KRO
Death
19
Injury
4,841
Total
4,860

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.