The following data is part of a premarket notification filed by Bioretec Ltd. with the FDA for Activapin Ht, Fuse Link (private Labled For Footmind, Inc.).
| Device ID | K133950 |
| 510k Number | K133950 |
| Device Name: | ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) |
| Classification | Pin, Fixation, Smooth |
| Applicant | BIORETEC LTD. HERMIANKATU 22, MODULIGTH BUILDING Tampere, FI Fi-33720 |
| Contact | Minna Rasanen |
| Correspondent | Minna Rasanen BIORETEC LTD. HERMIANKATU 22, MODULIGTH BUILDING Tampere, FI Fi-33720 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-01-22 |
| Summary: | summary |