The following data is part of a premarket notification filed by Pinnacle Spine Group, Llc with the FDA for Infill Intervertebral Body Fusion Device.
| Device ID | K103729 |
| 510k Number | K103729 |
| Device Name: | INFILL INTERVERTEBRAL BODY FUSION DEVICE |
| 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 | 2010-12-22 |
| Decision Date | 2011-04-18 |
| Summary: | summary |