The following data is part of a premarket notification filed by Medyssey Co., Ltd. with the FDA for C7 Anterior Cervical Intervertebral Fusion Cage.
Device ID | K121320 |
510k Number | K121320 |
Device Name: | C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | MEDYSSEY CO., LTD. 8001 N. LINCOLN AVE SUITE 401 Skokie, IL 60077 |
Contact | Michael Kvitnitsky |
Correspondent | Michael Kvitnitsky MEDYSSEY CO., LTD. 8001 N. LINCOLN AVE SUITE 401 Skokie, IL 60077 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-02 |
Decision Date | 2012-08-10 |
Summary: | summary |