The following data is part of a premarket notification filed by Synergy Biomedical, Llc with the FDA for Biosphere Mis Putty (biosphere Mis).
| Device ID | K173301 |
| 510k Number | K173301 |
| Device Name: | BioSphere MIS Putty (BioSphere MIS) |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Synergy Biomedical, Llc 100 Springhouse Dr. Suite 108 Collegeville, PA 19426 |
| Contact | Mark Borden |
| Correspondent | Randy Prebula Hogan Lovells U.S. Llp 555 Thirteenth Street N.W. Washington, DC 20004 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-17 |
| Decision Date | 2018-01-19 |
| Summary: | summary |