The following data is part of a premarket notification filed by Altus Partners, Llc with the FDA for Altus Spine Pedicle Screw System.
| Device ID | K200322 |
| 510k Number | K200322 |
| Device Name: | Altus Spine Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380 |
| Contact | Mark Melton |
| Correspondent | Mark Melton Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-10 |
| Decision Date | 2020-06-02 |