The following data is part of a premarket notification filed by Biogennix, Llc with the FDA for Sypher Spacer System.
| Device ID | K181337 |
| 510k Number | K181337 |
| Device Name: | Sypher Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Biogennix, LLC 18007 Sky Park Circle, Suite F Irvine, CA 92614 |
| Contact | Tim Bumbalough |
| Correspondent | Daniel Johnson JALEX Medical, LLC. 30311 Clemens Rd. Suite 5D Westlake, OH 44145 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-21 |
| Decision Date | 2018-09-18 |
| Summary: | summary |