The following data is part of a premarket notification filed by Apatech Ltd. with the FDA for Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft Substitute.
| Device ID | K090850 |
| 510k Number | K090850 |
| Device Name: | ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | APATECH LTD. 15058 ARMEL DRIVE Oregon City, OR 97045 |
| Contact | Candace F Cederman |
| Correspondent | Candace F Cederman APATECH LTD. 15058 ARMEL DRIVE Oregon City, OR 97045 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2009-07-30 |
| Summary: | summary |