The following data is part of a premarket notification filed by Olsen Medical with the FDA for Olsen Medical Anterior Cervical Vertebrae Plate System.
| Device ID | K042073 |
| 510k Number | K042073 |
| Device Name: | OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | OLSEN MEDICAL 3001 WEST KENTUCKY ST. Louisville, KY 40211 |
| Contact | Terry Johnson |
| Correspondent | Terry Johnson OLSEN MEDICAL 3001 WEST KENTUCKY ST. Louisville, KY 40211 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-02 |
| Decision Date | 2005-02-07 |
| Summary: | summary |