The following data is part of a premarket notification filed by Stryker Spine with the FDA for Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, And Trio Trauma Spinal.
| Device ID | K133188 |
| 510k Number | K133188 |
| Device Name: | MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Soraya King |
| Correspondent | Soraya King STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2013-12-17 |
| Summary: | summary |