The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Orion Anterior Cervical Plating System.
| Device ID | K042235 |
| 510k Number | K042235 |
| Device Name: | ORION ANTERIOR CERVICAL PLATING SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-18 |
| Decision Date | 2004-09-17 |
| Summary: | summary |