DeviceClearance

K103835

Substantially Equivalent

REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N

Applicant
Howmedica Osteonics Corp.
Product code
KWS
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mahwah, NJ, 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.