Apatech , Ltd.
Medical device manufacturer in Elstree, Unit.
8510(k) clearances
0PMA approvals
1recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K090850 | Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft SubstituteLYC · Traditional | 07/30/2009SE |
| K082575 | Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft SubstitutesMQV · Traditional | 11/25/2008SE |
| K081979 | Actifuse Bone Graft Substitute and E-Z-Fil and Shape Bone Graft SubstituteMQV · Traditional | 11/06/2008SE |
| K082073 | Actifuse Flow Bone Graft SubstituteMQV · Traditional | 09/11/2008SE |
| K080736 | Actifuse Shape Bone Graft SubstituteMQV · Special | 04/16/2008SE |
| K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteMQV · Special | 05/31/2007SE |
| K040082 | Pore-Si Bone Graft SubstituteMQV · Abbreviated | 08/04/2004SE |
| K033722 | Apapore Bone Graft SubstituteMQV · Abbreviated | 05/07/2004SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1922-2016 Class II | Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic…Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System… | 08/18/2015Terminated |