DeviceClearance

K223441

Substantially Equivalent

SpaceFlex Acetabular Cup

Applicant
G21, S.R.L.
Product code
KWY
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Possidonio, IT
Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY
Death
3
Injury
2,049
Total
2,052

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.