The following data is part of a premarket notification filed by Scient'x with the FDA for Polyaxial Hemispherical Spinal Screws.
| Device ID | K051063 |
| 510k Number | K051063 |
| Device Name: | POLYAXIAL HEMISPHERICAL SPINAL SCREWS |
| Classification | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-26 |
| Decision Date | 2005-05-23 |
| Summary: | summary |