SpaceFlex Knee— 510(k) K190216

Substantially Equivalent

G21, S.R.L.

FDA 510(k) clearance K190216 for SpaceFlex Knee, Substantially Equivalent on 2019-06-09. Applicant: G21, S.R.L..

Clearance details

Applicant: G21, S.R.L.
Product code: Code MBB
Advisory panel: Orthopedic
Date received: 2019-02-04
Decision date: 2019-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Possidomio, IT

Download summary PDF View on FDA.gov ↗

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.