The following data is part of a premarket notification filed by Biogennix with the FDA for Osteospan Morpheus.
| Device ID | K142828 |
| 510k Number | K142828 |
| Device Name: | OsteoSPAN Morpheus |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOGENNIX 18011 Sky Park Circle, Ste M Irvine, CA 92614 |
| Contact | Edwin Clayton Shors |
| Correspondent | Elaine Duncan Paladin Medical, Inc. 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 | 2014-09-30 |
| Decision Date | 2015-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812593020668 | K142828 | 000 |
| 00812593020439 | K142828 | 000 |
| 00812593020446 | K142828 | 000 |
| 00812593020378 | K142828 | 000 |
| 00812593020408 | K142828 | 000 |
| 00812593020415 | K142828 | 000 |
| 00812593020347 | K142828 | 000 |
| 00812593020354 | K142828 | 000 |
| 00812593020361 | K142828 | 000 |
| 00812593020637 | K142828 | 000 |
| 00812593020644 | K142828 | 000 |
| 00812593020651 | K142828 | 000 |
| 00812593020422 | K142828 | 000 |