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 | K121476 |
| 510k Number | K121476 |
| Device Name: | INFILL GRAFT DELIVERY SYSTEM |
| Classification | Syringe, Piston |
| Applicant | PINNACLE SPINE GROUP, LLC 1601 Elm St Ste 1930 Dallas, TX 75201 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine PINNACLE SPINE GROUP, LLC 1601 Elm St Ste 1930 Dallas, TX 75201 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-18 |
| Decision Date | 2012-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814729026162 | K121476 | 000 |