The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Vu Cpod, Zuma-c, Complete Cervical.
Device ID | K172926 |
510k Number | K172926 |
Device Name: | SeaSpine Vu CPOD, Zuma-C, Complete Cervical |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
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 | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-25 |
Decision Date | 2017-12-21 |
Summary: | summary |