G1 40 Radiopaque Bone Cement— 510(k) K193059

Name: FDA 510(k) clearance K193059
Creator: U.S. Food and Drug Administration
Published: 2020-03-19

Substantially Equivalent

G21, S.R.L.

FDA 510(k) clearance K193059 for G1 40 Radiopaque Bone Cement, Substantially Equivalent on 2020-03-19. Applicant: G21, S.R.L.. Device class: 2.

Clearance details

Applicant: G21, S.R.L.
Product code: Code LOD
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2019-11-01
Decision date: 2020-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Possidonio, IT

Download summary PDF View on FDA.gov ↗

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K202338 — SpaceFlex Shoulder2021-02-17
K201960 — SpaceFlex Knee - 80mm Size2020-08-13
K193061 — G3 40 Radiopaque Bone Cement2020-03-19

Adverse events under product code LOD

product code LOD

Death: 44
Injury: 3,004
Malfunction: 895
Other: 4
Total: 3,947

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.