Musculoskeletal Transplant Foundation, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 24
- Inspections
- 25
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1067-2024 | Class II | AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler) | December 22, 2023 |
| Z-1066-2024 | Class II | AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler) | December 22, 2023 |
| Z-0323-2024 | Class II | DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defec | September 22, 2023 |
| Z-1562-2021 | Class II | AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous | March 29, 2021 |
| Z-2548-2019 | Class II | QuickGraft¿ Model # 430PST | August 15, 2019 |
| Z-2004-2016 | Class II | Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of su | April 21, 2016 |
| Z-2075-2015 | Class II | Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are design | May 27, 2015 |
| Z-2210-2015 | Class II | Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze. | May 27, 2015 |
| Z-1455-2015 | Class II | DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler. | December 4, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K181633 | MTF Pre-Sutured Tendon | March 15, 2019 |
| K121313 | MTF NEW BONE VOID FILLER | January 11, 2013 |
| K120479 | MTF FASCIA | November 8, 2012 |
| K113167 | MTF NEW BONE VOILD FILLER | January 24, 2012 |
| K110003 | MTF NEW BONE VOID FILLER | October 13, 2011 |
| K103795 | DBX DEMINERALIZED BONE MATRIX PUTTY | April 13, 2011 |
| K103784 | DBX DEMINERALIZED BONE MATRIX PUTTY | April 13, 2011 |
| K091217 | DBX DEMINERALIZED BONE MATRIX PUTTY | October 2, 2009 |
| K091218 | DBX DEMINERALIZED BONE MATRIX PUTTY | September 28, 2009 |
| K080399 | DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE | October 10, 2008 |
| K080405 | SYGNAL DBM | August 28, 2008 |
| K073329 | SYGNAL DBM | February 28, 2008 |
| K070347 | ALLOFIX PUSH-IN ANCHOR | May 11, 2007 |
| K063676 | DBX DEMINERALIZED BONE MATRIX MIX | March 5, 2007 |
| K062205 | DBX STRIP | February 5, 2007 |
| K053218 | DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX | December 28, 2006 |
| K061498 | ALLOFIX ANCHOR, 5.0 MM ANCHOR | July 6, 2006 |
| K060161 | AFT ALLOGRAFT FILLER TUBE | March 21, 2006 |
| K053339 | ALLOFIX ANCHOR | March 16, 2006 |
| K042829 | DBX STRIP | January 13, 2006 |