The following data is part of a premarket notification filed by Pinnacle Spine Group, Llc with the FDA for Infill Graft Delivery System.
| Device ID | K111632 |
| 510k Number | K111632 |
| Device Name: | INFILL GRAFT DELIVERY SYSTEM |
| Classification | Syringe, Piston |
| Applicant | PINNACLE SPINE GROUP, LLC 1601 ELM STREET, SUITE 300 Dallas, TX 75201 |
| Contact | Rebecca K Spine |
| Correspondent | Rebecca K Spine PINNACLE SPINE GROUP, LLC 1601 ELM STREET, SUITE 300 Dallas, TX 75201 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-13 |
| Decision Date | 2011-08-11 |
| Summary: | summary |