BonOs HV Genta, BonOs MV Genta, BonOs LV Genta— 510(k) K210125

Clearance details

Applicant

Osartis GmbH

Product code

Code LOD

Device class

Class 2

Regulation

21 CFR 888.3027

Advisory panel

Orthopedic

Date received

2021-01-19

Decision date

2021-03-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Münster, DE

• K254107 — Refobacin Bone Cement R (110034355)2026-04-15
• K250760 — SPECTRUM GV Bone Cement2025-04-02
• K241674 — OSTEOPAL® V2024-12-05
• K231556 — SPECTRUM® GV Bone Cement2023-12-20
• K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV2023-01-09

• K240856 — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds2024-11-20
• K202458 — BonOs Inject, Pedicle screw kits, Cement pusher2021-05-18
• K210120 — BonOs HV, BonOs MV, BonOs LV2021-03-19
• K192394 — Hi-Fatigue Bone Cement2019-12-02
• K192379 — Hi-Fatigue G Bone Cement2019-11-27

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 →