MBP — Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Class II
FDA product code MBP covers "Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)", a Class II medical device regulated under 21 CFR 888.3045. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MBP
- Device Class
- Class II
- Regulation Number
- 888.3045
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242799 | lifenet health | PliaFX Flo | November 21, 2024 |
| K143547 | vivorte | Vivorte Trabexus EB | January 14, 2015 |
| K130703 | vivorte | VIVORTE BVF | September 12, 2013 |
| K130498 | bacterin international | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | May 31, 2013 |
| K122513 | medtronic sofamor danek | CLEARED UNDER GRAFTON II EDBM | March 6, 2013 |
| K113728 | hans biomed | SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY | November 15, 2012 |
| K103742 | integra life sciences | ACCELL EVO3 (FORMERLY ACCELL A2I) | March 17, 2011 |
| K091193 | isotis orthobiologics | ACCELL EVO3C | August 10, 2009 |
| K080399 | musculoskeletal transplant foundation | DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE | October 10, 2008 |
| K081817 | isotis orthobiologics | ACCELL TBM-R | September 24, 2008 |
| K080405 | musculoskeletal transplant foundation | SYGNAL DBM | August 28, 2008 |
| K080329 | etex | CAP PLUS, EQUIVABONE, CAP/DBM | April 28, 2008 |
| K073329 | musculoskeletal transplant foundation | SYGNAL DBM | February 28, 2008 |
| K063685 | exactech | OPTECURE; OPTECURE + CCC | June 7, 2007 |
| K063676 | musculoskeletal transplant foundation | DBX DEMINERALIZED BONE MATRIX MIX | March 5, 2007 |
| K061131 | orthocon | DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY | February 8, 2007 |
| K061982 | osteotech | PLEXUR P | February 7, 2007 |
| K062205 | musculoskeletal transplant foundation | DBX STRIP | February 5, 2007 |
| K060794 | medtronic sofamor danek | PROGENIX DBM PUTTY AND PASTE | December 18, 2006 |
| K061668 | exactech | OPTECURE +CCC | September 12, 2006 |