Product code MBP
- Device name
- Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3045
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242799 | PliaFX Flo | Lifenet Health | 2024-11-21 |
| K143547 | Vivorte Trabexus EB | Vivorte, Inc. | 2015-01-14 |
| K130703 | VIVORTE BVF | Vivorte, Inc. | 2013-09-12 |
| K130498 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | Bacterin International, Inc. | 2013-05-31 |
| K122513 | CLEARED UNDER GRAFTON II EDBM | Medtronic Sofamor Danek, Inc. | 2013-03-06 |
| K113728 | SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY | Hans Biomed Corp. | 2012-11-15 |
| K103742 | ACCELL EVO3 (FORMERLY ACCELL A2I) | Integra Life Sciences | 2011-03-17 |
| K091193 | ACCELL EVO3C | Isotis Orthobiologics, Inc. | 2009-08-10 |
| K080399 | DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE | Musculoskeletal Transplant Foundation | 2008-10-10 |
| K081817 | ACCELL TBM-R | Isotis Orthobiologics, Inc. | 2008-09-24 |
| K080405 | SYGNAL DBM | Musculoskeletal Transplant Foundation | 2008-08-28 |
| K080329 | CAP PLUS, EQUIVABONE, CAP/DBM | Etex Corp. | 2008-04-28 |
| K073329 | SYGNAL DBM | Musculoskeletal Transplant Foundation | 2008-02-28 |
| K063685 | OPTECURE; OPTECURE + CCC | Exactech, Inc. | 2007-06-07 |
| K063676 | DBX DEMINERALIZED BONE MATRIX MIX | Musculoskeletal Transplant Foundation | 2007-03-05 |
| K061131 | DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY | Orthocon, Inc. | 2007-02-08 |
| K061982 | PLEXUR P | Osteotech, Inc. | 2007-02-07 |
| K062205 | DBX STRIP | Musculoskeletal Transplant Foundation | 2007-02-05 |
| K060794 | PROGENIX DBM PUTTY AND PASTE | Medtronic Sofamor Danek | 2006-12-18 |
| K061668 | OPTECURE +CCC | Exactech, Inc. | 2006-09-12 |
| K060180 | BIOSET XC | Regeneration Technologies, Inc. | 2006-09-06 |
| K060161 | AFT ALLOGRAFT FILLER TUBE | Musculoskeletal Transplant Foundation | 2006-03-21 |
| K050806 | OPTECURE | Exactech, Inc. | 2006-02-08 |
| K053642 | OSTEOSET DBM PELLETS | Wrightmedicaltechnologyinc | 2006-01-26 |
| K042829 | DBX STRIP | Musculoskeletal Transplant Foundation | 2006-01-13 |
| K052735 | ALLOCRAFT DBM | Lifecell Corp. | 2005-12-28 |
| K051195 | GRAFTON DBM | Osteotech, Inc. | 2005-12-16 |
| K050642 | ORTHOBLAST II PUTTY AND PASTE | Isotis Orthobiologics, Inc. | 2005-12-05 |
| K043209 | VIAGRAF DBM PASTE | Osteotech, Inc. | 2005-12-05 |
| K053098 | OPTIUM DBM GEL AND PUTTY | Lifenet | 2005-11-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809204338665 | TruForm+ | Hans Biomed Corp. | 2017-07-18 |
| 08809204338658 | TruForm+ | Hans Biomed Corp. | 2017-07-18 |
| 08809204338641 | TruForm+ | Hans Biomed Corp. | 2017-07-18 |
| 08809204338634 | TruForm+ | Hans Biomed Corp. | 2017-07-18 |
| 08809204338627 | TruForm+ | Hans Biomed Corp. | 2017-07-18 |
| 08809204338610 | TruForm+ | Hans Biomed Corp. | 2017-07-18 |
| 08809204338603 | TruForm+ | Hans Biomed Corp. | 2017-07-18 |
| 08809204338597 | TruForm+ | Hans Biomed Corp. | 2017-07-18 |
| 08809204338580 | TruForm+ | Hans Biomed Corp. | 2017-07-18 |
| 08809204338498 | Exponent | Hans Biomed Corp. | 2017-03-09 |
| 07613327176971 | NA | Stryker Corporation | 2015-10-24 |
| 07613327177442 | BIO DBM | Stryker Corporation | 2015-10-24 |
| 07613327176940 | NA | Stryker Corporation | 2015-10-24 |
| 07613327176988 | NA | Stryker Corporation | 2015-10-24 |
| 07613327177008 | NA | Stryker Corporation | 2015-10-24 |
| 07613327177015 | NA | Stryker Corporation | 2015-10-24 |
| 07613327177022 | NA | Stryker Corporation | 2015-10-24 |
| 07613327177039 | NA | Stryker Corporation | 2015-10-24 |
| 07613327177374 | BIO DBM | Stryker Corporation | 2015-10-24 |
| 07613327177411 | BIO DBM | Stryker Corporation | 2015-10-24 |
| 07613327177435 | BIO DBM | Stryker Corporation | 2015-10-24 |
| 08809204337255 | ExFuse | Hans Biomed Corp. | 2015-09-24 |
| 08809204337583 | ExFuse | Hans Biomed Corp. | 2015-09-24 |
| 08809204337361 | ExFuse | Hans Biomed Corp. | 2015-09-24 |
| 08809204337354 | ExFuse | Hans Biomed Corp. | 2015-09-24 |
| 08809204337347 | ExFuse | Hans Biomed Corp. | 2015-09-24 |
| 08809204337330 | ExFuse | Hans Biomed Corp. | 2015-09-24 |
| 08809204337316 | ExFuse | Hans Biomed Corp. | 2015-09-24 |
| 08809204337293 | ExFuse | Hans Biomed Corp. | 2015-09-24 |
| 08809204337279 | ExFuse | Hans Biomed Corp. | 2015-09-24 |