DeviceClearance

K160555

Substantially Equivalent

BLUEPRINT Patient Specific Instrumentation

Applicant
Tornier S.A.S.
Product code
KWS
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Montbonnot-Saint-Martin, FR
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.