The following data is part of a premarket notification filed by Nv Cormed with the FDA for Nv Cormed Solas Spinal System.
| Device ID | K051959 |
| 510k Number | K051959 |
| Device Name: | NV CORMED SOLAS SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | NV CORMED 5349 RED LEAF COURT Oviedo, FL 32756 |
| Contact | Carl Knobloch |
| Correspondent | Carl Knobloch NV CORMED 5349 RED LEAF COURT Oviedo, FL 32756 |
| Product Code | MNH |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-18 |
| Decision Date | 2005-10-12 |
| Summary: | summary |