The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Mariner Pedicle Screw System.
Device ID | K160902 |
510k Number | K160902 |
Device Name: | Mariner Pedicle Screw System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | SEASPINE ORTHOPEDICS CORPORATION 5770 ARMADA DRIVE Carlsbad, CA 92008 |
Contact | Gina Flores |
Correspondent | Gina Flores SEASPINE ORTHOPEDICS CORPORATION 5770 ARMADA DRIVE Carlsbad, CA 92008 |
Product Code | NKB |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-04-01 |
Decision Date | 2016-05-26 |
Summary: | summary |