The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Coroent Small Interlock Ii System.
Device ID | K170961 |
510k Number | K170961 |
Device Name: | NuVasive CoRoent Small Interlock II System |
Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
Contact | Cynthia Adams |
Correspondent | Cynthia Adams NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
Product Code | OVE |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-31 |
Decision Date | 2017-06-08 |
Summary: | summary |