FDA Product Code
FDA Product Code MBP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3045
510(k) Clearances — 31 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242799 | PliaFX Flo | Lifenet Health | 2024-11-21 | Traditional | PDF ↗ |
| K143547 | Vivorte Trabexus EB | Vivorte, Inc. | 2015-01-14 | Special | PDF ↗ |
| K130703 | VIVORTE BVF | Vivorte, Inc. | 2013-09-12 | Traditional | PDF ↗ |
| K130498 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | Bacterin International, Inc. | 2013-05-31 | Traditional | PDF ↗ |
| K122513 | CLEARED UNDER GRAFTON II EDBM | Medtronic Sofamor Danek, Inc. | 2013-03-06 | Traditional | PDF ↗ |
| K113728 | SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY | Hans Biomed Corp. | 2012-11-15 | Traditional | PDF ↗ |
| K103742 | ACCELL EVO3 (FORMERLY ACCELL A2I) | Integra Life Sciences | 2011-03-17 | Traditional | PDF ↗ |
| K091193 | ACCELL EVO3C | Isotis Orthobiologics, Inc. | 2009-08-10 | Traditional | PDF ↗ |
| K080399 | DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE | Musculoskeletal Transplant Foundation | 2008-10-10 | Traditional | PDF ↗ |
| K081817 | ACCELL TBM-R | Isotis Orthobiologics, Inc. | 2008-09-24 | Traditional | PDF ↗ |
| K080405 | SYGNAL DBM | Musculoskeletal Transplant Foundation | 2008-08-28 | Traditional | PDF ↗ |
| K080329 | CAP PLUS, EQUIVABONE, CAP/DBM | Etex Corp. | 2008-04-28 | Traditional | PDF ↗ |
| K073329 | SYGNAL DBM | Musculoskeletal Transplant Foundation | 2008-02-28 | Traditional | PDF ↗ |
| K063685 | OPTECURE; OPTECURE + CCC | Exactech, Inc. | 2007-06-07 | Traditional | PDF ↗ |
| K063676 | DBX DEMINERALIZED BONE MATRIX MIX | Musculoskeletal Transplant Foundation | 2007-03-05 | Traditional | PDF ↗ |
| K061131 | DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY | Orthocon, Inc. | 2007-02-08 | Traditional | PDF ↗ |
| K061982 | PLEXUR P | Osteotech, Inc. | 2007-02-07 | Traditional | PDF ↗ |
| K062205 | DBX STRIP | Musculoskeletal Transplant Foundation | 2007-02-05 | Traditional | PDF ↗ |
| K060794 | PROGENIX DBM PUTTY AND PASTE | Medtronic Sofamor Danek | 2006-12-18 | Traditional | PDF ↗ |
| K061668 | OPTECURE +CCC | Exactech, Inc. | 2006-09-12 | Traditional | PDF ↗ |
| K060180 | BIOSET XC | Regeneration Technologies, Inc. | 2006-09-06 | Traditional | PDF ↗ |
| K060161 | AFT ALLOGRAFT FILLER TUBE | Musculoskeletal Transplant Foundation | 2006-03-21 | Traditional | PDF ↗ |
| K050806 | OPTECURE | Exactech, Inc. | 2006-02-08 | Traditional | PDF ↗ |
| K053642 | OSTEOSET DBM PELLETS | Wrightmedicaltechnologyinc | 2006-01-26 | Special | PDF ↗ |
| K042829 | DBX STRIP | Musculoskeletal Transplant Foundation | 2006-01-13 | Traditional | PDF ↗ |
| K052735 | ALLOCRAFT DBM | Lifecell Corp. | 2005-12-28 | Traditional | PDF ↗ |
| K051195 | GRAFTON DBM | Osteotech, Inc. | 2005-12-16 | Traditional | PDF ↗ |
| K043209 | VIAGRAF DBM PASTE | Osteotech, Inc. | 2005-12-05 | Traditional | PDF ↗ |
| K050642 | ORTHOBLAST II PUTTY AND PASTE | Isotis Orthobiologics, Inc. | 2005-12-05 | Traditional | PDF ↗ |
| K053098 | OPTIUM DBM GEL AND PUTTY | Lifenet | 2005-11-28 | Traditional | PDF ↗ |
| K043048 | GRAFTON PLUS DBM PASTE | Osteotech, Inc. | 2005-11-23 | Traditional | PDF ↗ |
Product code MBP · Class II · Orthopedic. Data: openFDA.