The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Medyssey Anterior Cervical Fusion Cage.
Device ID | K132732 |
510k Number | K132732 |
Device Name: | MEDYSSEY ANTERIOR CERVICAL FUSION CAGE |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | MEDYSSEY USA, INC. 1550 E. HIGGINS ROAD, STE 123 Elk Grove Village, IL 60007 |
Contact | John Kuczynski |
Correspondent | John Kuczynski MEDYSSEY USA, INC. 1550 E. HIGGINS ROAD, STE 123 Elk Grove Village, IL 60007 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-03 |
Decision Date | 2014-07-18 |