The following data is part of a premarket notification filed by Transcorp, Inc. with the FDA for Transcorp Trans-plate Anterior Cervical Plate System.
| Device ID | K092695 |
| 510k Number | K092695 |
| Device Name: | TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | TRANSCORP, INC. 1000 100TH ST. SW, SUITE F Byron Center, MI |
| Contact | Andrew Rodenhouse |
| Correspondent | Andrew Rodenhouse TRANSCORP, INC. 1000 100TH ST. SW, SUITE F Byron Center, MI |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-02 |
| Decision Date | 2010-05-21 |
| Summary: | summary |