The following data is part of a premarket notification filed by Bioretec Ltd with the FDA for Activascrew.
| Device ID | K072848 |
| 510k Number | K072848 |
| Device Name: | ACTIVASCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | BIORETEC LTD HERMIANKATU 22 MODULIGHT BLDG Tampere, FI Fi-33720 |
| Contact | Mari Ruotsalainen |
| Correspondent | Mari Ruotsalainen BIORETEC LTD HERMIANKATU 22 MODULIGHT BLDG Tampere, FI Fi-33720 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-04 |
| Decision Date | 2007-11-02 |