Smartset GMV Endurance Gentamicin Bone Cement
FDA 510(k) K033382 · DePuy Orthopaedics, Inc.
510(k) numberK033382
Submission
- Device name
- Smartset GMV Endurance Gentamicin Bone Cement
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- October 23, 2003
- Decision date
- February 5, 2004
- 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
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| 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 |
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| 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 Smartset GMV Endurance Gentamicin Bone Cement cleared by the FDA?
Smartset GMV Endurance Gentamicin Bone Cement (K033382) received a 510(k) decision of Substantially Equivalent on February 5, 2004, 105 days after the submission was received.
What is the product code of K033382?
The FDA product code is LOD – Bone Cement, a Class II (moderate risk) device regulated under 21 CFR 888.3027.