The following data is part of a premarket notification filed by Scient'x Usa, Inc. with the FDA for Davantis/antelys Vertebral Body Replacements.
| Device ID | K053292 |
| 510k Number | K053292 |
| Device Name: | DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SCIENT'X USA, INC. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb SCIENT'X USA, INC. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-25 |
| Decision Date | 2006-01-19 |
| Summary: | summary |