The following data is part of a premarket notification filed by Osseus Fusion Systems, Llc with the FDA for Osseus Black Diamond Pedicle Screw System.
| Device ID | K131810 |
| 510k Number | K131810 |
| Device Name: | OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | OSSEUS FUSION SYSTEMS, LLC 1001 OACKWOOD BLVD Round Rock, TX 75205 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb OSSEUS FUSION SYSTEMS, LLC 1001 OACKWOOD BLVD Round Rock, TX 75205 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-19 |
| Decision Date | 2013-08-08 |
| Summary: | summary |