The following data is part of a premarket notification filed by Black Box Medical Llc with the FDA for Pedicle Screw System.
| Device ID | K201751 |
| 510k Number | K201751 |
| Device Name: | Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Black Box Medical LLC 4516 East County Road 45 Midland, TX 79705 |
| Contact | Todd Stanaford |
| Correspondent | Daniel Lanois SurgOp Support LLC 101 Lamond Ct Prosper, TX 75078 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-26 |
| Decision Date | 2020-07-22 |