The following data is part of a premarket notification filed by Biogennix, Llc with the FDA for Osteospan Morpheus.
| Device ID | K132377 |
| 510k Number | K132377 |
| Device Name: | OSTEOSPAN MORPHEUS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOGENNIX, LLC P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan BIOGENNIX, LLC P.O. 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 | 2013-07-31 |
| Decision Date | 2014-05-20 |
| Summary: | summary |