The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Coroent No-profile System.
Device ID | K112561 |
510k Number | K112561 |
Device Name: | NUVASIVE COROENT NO-PROFILE SYSTEM |
Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
Contact | Sheila Bruschi |
Correspondent | Sheila Bruschi NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
Product Code | OVD |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-02 |
Decision Date | 2012-03-13 |
Summary: | summary |