MQVClass II
Filler, Bone Void, Calcium Compound
21 CFR 888.3045 / Orthopedic
MQV is the FDA product code for Filler, Bone Void, Calcium Compound, a class II device type, regulated under 21 CFR 888.3045. As of , FDA records hold 492 510(k) clearances under this code, the most recent dated , and 120 recalls.
Classification record
- Product code
- MQV
- Device name
- Filler, Bone Void, Calcium Compound
- Regulation
- 21 CFR 888.3045
- 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
- 493
- Ingested recalls
- 120
Clearances, product code MQV
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 5 |
| 2001 | 9 |
| 2002 | 14 |
| 2003 | 24 |
| 2004 | 34 |
| 2005 | 33 |
| 2006 | 23 |
| 2007 | 35 |
| 2008 | 32 |
| 2009 | 23 |
| 2010 | 17 |
| 2011 | 16 |
| 2012 | 9 |
| 2013 | 12 |
| 2014 | 20 |
| 2015 | 18 |
| 2016 | 8 |
| 2017 | 17 |
| 2018 | 23 |
| 2019 | 13 |
| 2020 | 15 |
| 2021 | 8 |
| 2022 | 9 |
| 2023 | 21 |
| 2024 | 28 |
| 2025 | 14 |
| 2026 | 5 |
Applicants with the most clearances
Product code MQV| Applicant | Clearances |
|---|---|
| Wrightmedicaltechnologyinc | 28 |
| Novabone Products, LLC | 19 |
| DSM Biomedical, Inc. | 16 |
| Berkeley Advanced Biomaterials | 14 |
| Etex Corp. | 13 |
| RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 13 |
| Kuros Biosciences BV | 12 |
| Biocomposites, Ltd. | 11 |
| Medtronic Sofamor Danek | 11 |
| Baxter Healthcare Corporation | 10 |
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.
