MQPClass II
Spinal Vertebral Body Replacement Device
21 CFR 888.3060 / Orthopedic
MQP is the FDA product code for Spinal Vertebral Body Replacement Device, a class II device type, regulated under 21 CFR 888.3060. As of , FDA records hold 279 510(k) clearances under this code, the most recent dated , and 46 recalls.
Classification record
- Product code
- MQP
- Device name
- Spinal Vertebral Body Replacement Device
- Regulation
- 21 CFR 888.3060
- 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
- 279
- Ingested recalls
- 46
Clearances, product code MQP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 11 |
| 2002 | 13 |
| 2003 | 23 |
| 2004 | 31 |
| 2005 | 37 |
| 2006 | 31 |
| 2007 | 30 |
| 2008 | 17 |
| 2009 | 11 |
| 2010 | 6 |
| 2011 | 8 |
| 2012 | 7 |
| 2013 | 3 |
| 2014 | 5 |
| 2015 | 8 |
| 2017 | 9 |
| 2018 | 6 |
| 2019 | 8 |
| 2020 | 3 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 4 |
| 2026 | 3 |
Applicants with the most clearances
Product code MQP| Applicant | Clearances |
|---|---|
| Medtronic Sofamor Danek | 30 |
| Globus Medical, Inc. | 11 |
| Interpore Cross Intl. | 10 |
| Spine Wave Inc | 10 |
| Howmedica Osteonics Corp | 9 |
| Depuyacromed | 8 |
| Implex Corp. | 8 |
| K2M, Inc | 8 |
| Ldr Spine USA | 8 |
| Signus Medizintechnik GmbH | 8 |
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.
