The following data is part of a premarket notification filed by Scien'tx Usa Inc. with the FDA for Anterior Cervical Plate System.
| Device ID | K013439 |
| 510k Number | K013439 |
| Device Name: | ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SCIEN'TX USA INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Joanna Droege |
| Correspondent | Joanna Droege SCIEN'TX USA INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-17 |
| Decision Date | 2002-01-14 |
| Summary: | summary |