The following data is part of a premarket notification filed by Biogennix, Llc. with the FDA for Morpheus-c.
| Device ID | K190371 |
| 510k Number | K190371 |
| Device Name: | Morpheus-C |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Biogennix, LLC. 1641 McGaw Ave Irvine, CA 92614 |
| Contact | Timothy Bumbalough |
| Correspondent | Elaine Duncan Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-15 |
| Decision Date | 2019-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812593020705 | K190371 | 000 |
| 00812593021696 | K190371 | 000 |
| 00812593021702 | K190371 | 000 |
| 00812593021719 | K190371 | 000 |
| 00812593021627 | K190371 | 000 |
| 00812593021634 | K190371 | 000 |
| 00812593021641 | K190371 | 000 |
| 00812593021658 | K190371 | 000 |
| 00812593022211 | K190371 | 000 |
| 00812593022228 | K190371 | 000 |
| 00812593022235 | K190371 | 000 |
| 00812593022242 | K190371 | 000 |
| 00812593020675 | K190371 | 000 |
| 00812593020682 | K190371 | 000 |
| 00812593020699 | K190371 | 000 |
| 00812593021689 | K190371 | 000 |