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 | K091944 |
| 510k Number | K091944 |
| Device Name: | MODIFICATION TO: DSS STABILIZATION SYSTEM |
| Classification | Posterior Metal/polymer Spinal System, Fusion |
| 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 | NQP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2009-08-03 |
| Summary: | summary |