The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Coroent System.
Device ID | K081611 |
510k Number | K081611 |
Device Name: | NUVASIVE COROENT SYSTEM |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
Contact | Laetitia Cousin |
Correspondent | Laetitia Cousin NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-09 |
Decision Date | 2008-10-02 |
Summary: | summary |