The following data is part of a premarket notification filed by Spinal Surgical Strategies, Llc with the FDA for Bi-portal Bone Graft Delivery Device.
| Device ID | K142661 |
| 510k Number | K142661 |
| Device Name: | Bi-Portal Bone Graft Delivery Device |
| Classification | Syringe, Piston |
| Applicant | Spinal Surgical Strategies, LLC 999 Driver Way Incline Village, NV 89541 |
| Contact | Jeffrey Kleiner |
| Correspondent | Tim Reeves c/o Spinal Surgical Strategies 999 Driver Way Incline Village, NV 89541 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-18 |
| Decision Date | 2014-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863462000205 | K142661 | 000 |