The following data is part of a premarket notification filed by Synergy Biomedical, Llc with the FDA for Biosphere Bioactive Bone Graft Putty.
| Device ID | K122868 |
| 510k Number | K122868 |
| Device Name: | BIOSPHERE BIOACTIVE BONE GRAFT PUTTY |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Synergy Biomedical, LLC 555 THIRTEENTH STREET, NW Washington, DC 20009 |
| Contact | Randy Prebula |
| Correspondent | Randy Prebula Synergy Biomedical, LLC 555 THIRTEENTH STREET, NW Washington, DC 20009 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-18 |
| Decision Date | 2013-04-19 |
| Summary: | summary |