The following data is part of a premarket notification filed by Bio2 Technologies, Inc. with the FDA for Bio2 Clm Bg Bioactive Scaffold.
| Device ID | K142463 |
| 510k Number | K142463 |
| Device Name: | Bio2 CLM BG Bioactive Scaffold |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Bio2 Technologies, Inc. 12R Cabot Road Woburn, MA 01801 |
| Contact | Janet Krevolin, Phd |
| Correspondent | Janet Krevolin, Phd Bio2 Technologies, Inc. 12R Cabot Road Woburn, MA 01801 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-02 |
| Decision Date | 2014-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B01010000351 | K142463 | 000 |
| B01010000461 | K142463 | 000 |
| B01010000471 | K142463 | 000 |
| B01010000481 | K142463 | 000 |
| B01010000491 | K142463 | 000 |
| B01010000501 | K142463 | 000 |
| B01010000511 | K142463 | 000 |
| B01010000521 | K142463 | 000 |
| B01010000531 | K142463 | 000 |
| B01010000451 | K142463 | 000 |
| B01010000441 | K142463 | 000 |
| B01010000361 | K142463 | 000 |
| B01010000371 | K142463 | 000 |
| B01010000381 | K142463 | 000 |
| B01010000391 | K142463 | 000 |
| B01010000401 | K142463 | 000 |
| B01010000411 | K142463 | 000 |
| B01010000421 | K142463 | 000 |
| B01010000431 | K142463 | 000 |
| B01010000541 | K142463 | 000 |
| B01010000551 | K142463 | 000 |
| B01010000561 | K142463 | 000 |
| B01010000681 | K142463 | 000 |
| B01010000691 | K142463 | 000 |
| B01010000701 | K142463 | 000 |
| B01010000711 | K142463 | 000 |
| B01010000721 | K142463 | 000 |
| B01010002311 | K142463 | 000 |
| B01010002321 | K142463 | 000 |
| B0101000258 | K142463 | 000 |
| B01010000671 | K142463 | 000 |
| B01010000661 | K142463 | 000 |
| B01010000571 | K142463 | 000 |
| B01010000581 | K142463 | 000 |
| B01010000591 | K142463 | 000 |
| B01010000601 | K142463 | 000 |
| B01010000611 | K142463 | 000 |
| B01010000621 | K142463 | 000 |
| B01010000641 | K142463 | 000 |
| B01010000651 | K142463 | 000 |
| B0101000259 | K142463 | 000 |