The following data is part of a premarket notification filed by Scient'x with the FDA for Ellys And Aurys Vertebral Body Replacements.
| Device ID | K033109 |
| 510k Number | K033109 |
| Device Name: | ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS |
| Classification | Spinal Vertebral Body Replacement Device |
| 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 | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2004-03-23 |
| Summary: | summary |