Bone Cement Genta, Bone Cement HV, Bone Cement LV
FDA 510(k) K211163 · Tecres S.P.A.
510(k) numberK211163
Submission
- Device name
- Bone Cement Genta, Bone Cement HV, Bone Cement LV
- Applicant
- Tecres S.P.A.
Sommacampagna, IT - Received
- April 19, 2021
- Decision date
- January 9, 2023
- 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
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|---|---|---|---|
| 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 |
| 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 |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV GentaLOD · Traditional | Osartis GmbH | 03/19/2021SE |
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| K122175 | Mendec Spine HV, Mendec Spine HV SystemNDN · Traditional | 03/28/2013SE |
| K112983 | Spacer-SHSD · Traditional | 12/12/2011SE |
| K101356 | Spacer-G and Spacer-KKWL · Traditional | 09/20/2011SE |
| K092773 | Cemex Genta, Genta System and Genta System FastLOD · Special | 11/24/2009SE |
| K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321JWH · Traditional | 05/22/2008SE |
| K062273 | Spacer-G Temporary Hip ProsthesisKWL · Traditional | 05/22/2008SE |
| K063438 | VspspnNDN · Traditional | 01/17/2007SE |
Questions and answers
When was Bone Cement Genta, Bone Cement HV, Bone Cement LV cleared by the FDA?
Bone Cement Genta, Bone Cement HV, Bone Cement LV (K211163) received a 510(k) decision of Substantially Equivalent on January 9, 2023, 630 days after the submission was received.
What is the product code of K211163?
The FDA product code is LOD – Bone Cement, a Class II (moderate risk) device regulated under 21 CFR 888.3027.