The following data is part of a premarket notification filed by Synergy Biomedical with the FDA for Biosphere Flex.
| Device ID | K173424 |
| 510k Number | K173424 |
| Device Name: | BioSphere Flex |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Synergy Biomedical 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-01 |
| Decision Date | 2018-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M958BSF00075 | K173424 | 000 |
| M958BSF251000 | K173424 | 000 |
| M958BSF250500 | K173424 | 000 |
| M958BSF000400 | K173424 | 000 |
| M958BSF000300 | K173424 | 000 |