The following data is part of a premarket notification filed by Altus Partners, Llc with the FDA for Altus Spine Pedicle Screw System, Altus Spine Mis Pedicle Screw System, Valencia Pedicle Screw System, Valencia Mis Pedicle Screw System.
| Device ID | K151648 |
| 510k Number | K151648 |
| Device Name: | Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Altus Partners, LLC 5129 West Chester Pike Newtown Square, PA 19073 |
| Contact | Claudia Hill |
| Correspondent | Claudia Hill Altus Partners, LLC 5129 West Chester Pike Newtown Square, PA 19073 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-18 |
| Decision Date | 2015-10-16 |
| Summary: | summary |