The following data is part of a premarket notification filed by Scient'x with the FDA for Stella Cervical Plate.
| Device ID | K052763 |
| 510k Number | K052763 |
| Device Name: | STELLA CERVICAL PLATE |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SCIENT'X 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J. D. Webb |
| Correspondent | J. D. Webb SCIENT'X 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2005-11-10 |
| Summary: | summary |