The following data is part of a premarket notification filed by Osseus Fusion Systems with the FDA for Black Diamond Pedicle Screw System.
| Device ID | K192121 |
| 510k Number | K192121 |
| Device Name: | Black Diamond Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Osseus Fusion Systems 2703 Mockingbird Lane, Suite 102 Dallas, TX 75235 |
| Contact | Robert Pace |
| Correspondent | J. D. Webb The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, UT 84401 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-06 |
| Decision Date | 2019-10-29 |
| Summary: | summary |