The following data is part of a premarket notification filed by Bioretec Ltd with the FDA for Activapin.
| Device ID | K061164 |
| 510k Number | K061164 |
| Device Name: | ACTIVAPIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | BIORETEC LTD HERMIAKATU 22 MODULIGHT BLDG Tamere, FI Fi-33720 |
| Contact | Mari Ruotsalainen |
| Correspondent | Mari Ruotsalainen BIORETEC LTD HERMIAKATU 22 MODULIGHT BLDG Tamere, FI Fi-33720 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-26 |
| Decision Date | 2006-07-06 |
| Summary: | summary |