The following data is part of a premarket notification filed by A Johnson & Johnson Company with the FDA for Skyline Anterior Cervical Plate System.
| Device ID | K103491 |
| 510k Number | K103491 |
| Device Name: | SKYLINE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Contact | Frank S Jurczak |
| Correspondent | Frank S Jurczak A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-26 |
| Decision Date | 2011-02-14 |
| Summary: | summary |