The following data is part of a premarket notification filed by Tyber Medical, Llc with the FDA for Tyber Medical Pt Interbody Spacer System.
| Device ID | K180590 |
| 510k Number | K180590 |
| Device Name: | Tyber Medical PT Interbody Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Tyber Medical, LLC 83 South Commerce Way Suite 310 Bethlehem, PA 18017 |
| Contact | Mark F Schenk |
| Correspondent | Mark F Schenk Tyber Medical, LLC 83 South Commerce Way Suite 310 Bethlehem, PA 18017 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-06 |
| Decision Date | 2018-07-06 |