G1 40 Radiopaque Bone Cement
FDA 510(k) K193059 · G21, S.R.L.
510(k) numberK193059
Submission
- Device name
- G1 40 Radiopaque Bone Cement
- Applicant
- G21, S.R.L.
San Possidonio, IT - Received
- November 1, 2019
- Decision date
- March 19, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LOD – Bone Cement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254107 | Refobacin Bone Cement R (110034355)LOD · Traditional | Biomet France | 04/15/2026SE |
| K250760 | SPECTRUM GV Bone CementLOD · Special | Osteoremedies, LLC | 04/02/2025SE |
| K241674 | Osteopal® VLOD · Traditional | Heraeus Medical GmbH | 12/05/2024SE |
| K231556 | SPECTRUM® GV Bone CementLOD · Traditional | Osteoremedies, LLC | 12/20/2023SE |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LVLOD · Traditional | Tecres S.P.A. | 01/09/2023SE |
| K212729 | Bone Cement-Normal ViscosityLOD · Traditional | Biomecanica Industria E Comerciode Produtos… | 05/31/2022SE |
| K211869 | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…LOD · Traditional | Ormed Grup Medikal Turizm Saglik Hizmetleri… | 05/19/2022SE |
| K213812 | PALACOS MV proLOD · Traditional | Heraeus Medical GmbH | 02/02/2022SE |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLOD · Traditional | Heraeus Medical GmbH | 07/09/2021SE |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusherLOD · Traditional | Osartis GmbH | 05/18/2021SE |
More from Osartis GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K252443 | SpaceFix Shoulder SpacerMBB · Traditional | 09/15/2025SE |
| K223441 | SpaceFlex Acetabular CupKWY · Traditional | 03/23/2023SE |
| K202338 | SpaceFlex ShoulderMBB · Traditional | 02/17/2021SE |
| K201960 | SpaceFlex Knee - 80mm SizeMBB · Special | 08/13/2020SE |
| K193061 | G3 40 Radiopaque Bone CementLOD · Traditional | 03/19/2020SE |
| K192041 | G21 SpaceFlex HipMBB · Traditional | 10/29/2019SE |
| K190216 | SpaceFlex KneeMBB · Traditional | 06/09/2019SE |
| K181282 | G3A 40 Bone CementLOD · Traditional | 01/09/2019SE |
| K173494 | OrthoSteady G Bone CementLOD · Traditional | 03/06/2018SE |
| K152557 | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersNDN · Traditional | 02/23/2016SE |
Questions and answers
When was G1 40 Radiopaque Bone Cement cleared by the FDA?
G1 40 Radiopaque Bone Cement (K193059) received a 510(k) decision of Substantially Equivalent on March 19, 2020, 139 days after the submission was received.
What is the product code of K193059?
The FDA product code is LOD – Bone Cement, a Class II (moderate risk) device regulated under 21 CFR 888.3027.