510(k) K252443— SpaceFix Shoulder Spacer

Substantially Equivalent

G21, S.R.L.

Clearance details

Applicant: G21, S.R.L.
Product code: Code MBB
Advisory panel: Orthopedic
Date received: 2025-08-04
Decision date: 2025-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Possidonio, IT

Adverse events under product code MBB

product code MBB

Death: 27
Injury: 1,412
Malfunction: 551
Total: 1,990

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.