The following data is part of a premarket notification filed by Synergy Biomedical, Inc. with the FDA for Biosphere Bioactive Bone Graft Putty, 2.5cc, 5cc, 10cc.
| Device ID | K140844 |
| 510k Number | K140844 |
| Device Name: | BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SYNERGY BIOMEDICAL, INC. 555 THIRTEENTH ST, N.W. Washington, DC 20009 |
| Contact | Randy Prebula |
| Correspondent | Randy Prebula SYNERGY BIOMEDICAL, INC. 555 THIRTEENTH ST, N.W. 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 | 2014-04-02 |
| Decision Date | 2014-07-16 |
| Summary: | summary |