The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Spinous Process System.
Device ID | K173334 |
510k Number | K173334 |
Device Name: | SeaSpine Spinous Process System |
Classification | Spinous Process Plate |
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 | PEK |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-23 |
Decision Date | 2018-02-22 |
Summary: | summary |