Depuy CMW 1, 2 and 3 Bone Cements
FDA 510(k) K053003 · DePuy Orthopaedics, Inc.
510(k) numberK053003
Submission
- Device name
- Depuy CMW 1, 2 and 3 Bone Cements
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- October 26, 2005
- Decision date
- November 22, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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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 |
| 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 |
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Questions and answers
When was Depuy CMW 1, 2 and 3 Bone Cements cleared by the FDA?
Depuy CMW 1, 2 and 3 Bone Cements (K053003) received a 510(k) decision of Substantially Equivalent on November 22, 2005, 27 days after the submission was received.
What is the product code of K053003?
The FDA product code is LOD – Bone Cement, a Class II (moderate risk) device regulated under 21 CFR 888.3027.