The following data is part of a premarket notification filed by Apatech Ltd. with the FDA for Actifuse Bone Graft Substitute And E-z-fil And Shape Bone Graft Substitute.
| Device ID | K081979 |
| 510k Number | K081979 |
| Device Name: | ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| 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 | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-11 |
| Decision Date | 2008-11-06 |
| Summary: | summary |