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 |