The following data is part of a premarket notification filed by Innovative Spinal Design, Llc with the FDA for Verteview Anterior Cervical Plate System.
| Device ID | K050588 |
| 510k Number | K050588 |
| Device Name: | VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | INNOVATIVE SPINAL DESIGN, LLC 1555 JUPITER PARK DR., #4 Jupiter, FL 33458 |
| Contact | Leigh Cowden |
| Correspondent | Leigh Cowden INNOVATIVE SPINAL DESIGN, LLC 1555 JUPITER PARK DR., #4 Jupiter, FL 33458 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-08 |
| Decision Date | 2005-04-21 |
| Summary: | summary |