The following data is part of a premarket notification filed by Paradigm Spine with the FDA for Dss Stabilization System.
| Device ID | K080963 |
| 510k Number | K080963 |
| Device Name: | DSS STABILIZATION SYSTEM |
| Classification | Posterior Metal/polymer Spinal System, Fusion |
| Applicant | PARADIGM SPINE 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton PARADIGM SPINE 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | NQP |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-04 |
| Decision Date | 2008-05-02 |
| Summary: | summary |