OSTEOPAL plus
FDA 510(k) K153737 · Heraeus Medical GmbH
510(k) numberK153737
Submission
- Device name
- OSTEOPAL plus
- Applicant
- Heraeus Medical GmbH
Wehrheim, DE - Received
- December 28, 2015
- Decision date
- April 22, 2016
- 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
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 |
|---|---|---|
| K241674 | Osteopal® VLOD · Traditional | 12/05/2024SE |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+VKWL · Traditional | 02/15/2024SE |
| K222570 | COPAL knee mouldsJWH · Traditional | 02/04/2023SE |
| K220492 | COPAL exchange G hip spacerKWY · Special | 03/23/2022SE |
| K213812 | PALACOS MV proLOD · Traditional | 02/02/2022SE |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLOD · Traditional | 07/09/2021SE |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GLOD · Traditional | 11/23/2020SE |
| K191016 | COPAL exchange G Hip and Knee SpacersKWY · Traditional | 11/01/2019SE |
| K190766 | PALACOS fast R+GLOD · Traditional | 05/31/2019SE |
| K182260 | Palacos MVLOD · Special | 09/17/2018SE |
Questions and answers
When was OSTEOPAL plus cleared by the FDA?
OSTEOPAL plus (K153737) received a 510(k) decision of Substantially Equivalent on April 22, 2016, 116 days after the submission was received.
What is the product code of K153737?
The FDA product code is LOD – Bone Cement, a Class II (moderate risk) device regulated under 21 CFR 888.3027.