The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Envision Anterior Cervical Plate System.
| Device ID | K020649 |
| 510k Number | K020649 |
| Device Name: | ENVISION ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ORTHO DEVELOPMENT CORP. 12187 S. BUSINESS PARK DR. Draper, UT 84020 |
| Contact | Carol Freasier |
| Correspondent | Carol Freasier ORTHO DEVELOPMENT CORP. 12187 S. BUSINESS PARK DR. Draper, UT 84020 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-28 |
| Decision Date | 2002-04-05 |
| Summary: | summary |