LODClass II
Bone Cement
21 CFR 888.3027 / Orthopedic
LOD is the FDA product code for Bone Cement, a class II device type, regulated under 21 CFR 888.3027. As of , FDA records hold 72 510(k) clearances under this code, the most recent dated , and 34 recalls.
Classification record
- Product code
- LOD
- Device name
- Bone Cement
- Regulation
- 21 CFR 888.3027
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 72
- Ingested recalls
- 36
Clearances, product code LOD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 4 |
| 2002 | 3 |
| 2003 | 10 |
| 2004 | 8 |
| 2005 | 6 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 3 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 4 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 4 |
| 2020 | 3 |
| 2021 | 4 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code LOD| Applicant | Clearances |
|---|---|
| Depuy Orthopaedics Inc. | 9 |
| Heraeus Medical GmbH | 9 |
| Zimmer GmbH | 7 |
| Exactech, Inc. | 5 |
| Osartis GmbH | 5 |
| G21, S.r.l. | 4 |
| Heraeus Kulzer GmbH & Co. KG | 4 |
| Kulzer GmbH | 3 |
| Smith & Nephew, Inc. | 3 |
| Aap Biomaterials GmbH & Co. KG | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.