DeviceClearance

K191318

Substantially Equivalent

AEQUALIS FLEX REVIVE Shoulder System

Applicant
Tornier, Inc.
Product code
KWS
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Bloomington, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KWS

product code KWS
Death
6
Injury
9,652
Malfunction
1,385
Other
1
Total
11,044

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.