DeviceClearance

K143301

Substantially Equivalent

NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit

Applicant
Integrated Healing Technologies
Product code
OMP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Franklin, TN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OMP

product code OMP
Death
31
Injury
1,707
Malfunction
4,047
Other
1
Total
5,786

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.