The following data is part of a premarket notification filed by Pinnacle Spine Group, Llc with the FDA for Infill Interbody Fusion Devices.
| Device ID | K151184 |
| 510k Number | K151184 |
| Device Name: | InFill Interbody Fusion Devices |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | PINNACLE SPINE GROUP, LLC 1601 ELM STREET, SUITE 300 Dallas, TX 75201 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine PINNACLE SPINE GROUP, LLC 1601 ELM STREET, SUITE 300 Dallas, TX 75201 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-04 |
| Decision Date | 2015-07-14 |
| Summary: | summary |