The following data is part of a premarket notification filed by Bio2 Technologies, Inc with the FDA for Bio2 Fusion Implant System.
| Device ID | K151876 |
| 510k Number | K151876 |
| Device Name: | Bio2 Fusion Implant System |
| Classification | Pin, Fixation, Smooth |
| Applicant | Bio2 Technologies, Inc 12R Cabot Road Woburn, MA 01801 |
| Contact | Janet Krevolin |
| Correspondent | Janet Krevolin Bio2 Technologies, Inc 12R Cabot Road Woburn, MA 01801 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-09 |
| Decision Date | 2015-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B01010001321 | K151876 | 000 |
| B01010001301 | K151876 | 000 |
| B01010001291 | K151876 | 000 |