The following data is part of a premarket notification filed by Paradigm Spine, Llc with the FDA for Modification To: Dss Stabilization System.
| Device ID | K090408 |
| 510k Number | K090408 |
| Device Name: | MODIFICATION TO: DSS STABILIZATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | PARADIGM SPINE, LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Adam Herder |
| Correspondent | Adam Herder PARADIGM SPINE, LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-18 |
| Decision Date | 2009-03-20 |
| Summary: | summary |