The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Coroent Small Contoured Interbody System.
Device ID | K142050 |
510k Number | K142050 |
Device Name: | NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
Contact | Michelle Cheung |
Correspondent | Michelle Cheung NUVASIVE, INCORPORATED 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 | 2014-07-28 |
Decision Date | 2014-10-29 |
Summary: | summary |