The following data is part of a premarket notification filed by Scient'x Usa, Inc. with the FDA for Modification To Easys Transverse Connection.
| Device ID | K031290 |
| 510k Number | K031290 |
| Device Name: | MODIFICATION TO EASYS TRANSVERSE CONNECTION |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| 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 | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-23 |
| Decision Date | 2003-05-13 |
| Summary: | summary |