The following data is part of a premarket notification filed by Spinal Usa Llc with the FDA for Slimplicity Solo Anterior Cervical Plate System.
| Device ID | K112748 |
| 510k Number | K112748 |
| Device Name: | SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SPINAL USA LLC 2050 Executive Dr Pearl, MS 39208 |
| Contact | Frankie Cummins |
| Correspondent | Frankie Cummins SPINAL USA LLC 2050 Executive Dr Pearl, MS 39208 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-21 |
| Decision Date | 2012-07-11 |
| Summary: | summary |