The following data is part of a premarket notification filed by Paradigm Spine, Llc with the FDA for Dss Stabilization System.
| Device ID | K113625 |
| 510k Number | K113625 |
| Device Name: | DSS STABILIZATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | PARADIGM SPINE, LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Michelle Mcdonough |
| Correspondent | Michelle Mcdonough 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 | 2011-12-08 |
| Decision Date | 2012-01-10 |
| Summary: | summary |