MBPClass II
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
21 CFR 888.3045 / Orthopedic
MBP is the FDA product code for Filler, Bone Void, Osteoinduction (W/O Human Growth Factor), a class II device type, regulated under 21 CFR 888.3045. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and 41 recalls.
Classification record
- Product code
- MBP
- Device name
- Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
- 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
- 31
- Ingested recalls
- 41
Clearances, product code MBP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2005 | 6 |
| 2006 | 7 |
| 2007 | 5 |
| 2008 | 5 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 3 |
| 2015 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code MBP| Applicant | Clearances |
|---|---|
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | 7 |
| Osteotech Inc | 4 |
| Exactech, Inc. | 3 |
| IsoTis OrthoBiologics, Inc. | 3 |
| Medtronic Sofamor Danek | 2 |
| Vivorte, Inc. | 2 |
| Xtant Medical Holdings, Inc. | 1 |
| Etex Corp. | 1 |
| Hans Biomed Corp. | 1 |
| Integra Pain Management | 1 |
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.