SpaceFlex Acetabular Cup— 510(k) K223441

Substantially Equivalent

G21, S.R.L.

FDA 510(k) clearance K223441 for SpaceFlex Acetabular Cup, Substantially Equivalent on 2023-03-23. Applicant: G21, S.R.L..

Clearance details

Applicant: G21, S.R.L.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2022-11-14
Decision date: 2023-03-23
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, 2020-01-01 through 2026-04-23. 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.