The following data is part of a premarket notification filed by Nuvasive Incorporated with the FDA for Nuvasive® Coroent® Small Interlock™ System.
Device ID | K161442 |
510k Number | K161442 |
Device Name: | NuVasive® CoRoent® Small Interlock™ System |
Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
Applicant | NUVASIVE INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
Contact | Cynthia Adams |
Correspondent | Cynthia Adams NUVASIVE INCORPORATED 7475 LUSK BOULEVARD 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 | 2016-05-25 |
Decision Date | 2016-09-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00887517943125 | K161442 | 000 |
00887517711557 | K161442 | 000 |
00887517711564 | K161442 | 000 |
00887517711571 | K161442 | 000 |
00887517711588 | K161442 | 000 |
00887517711595 | K161442 | 000 |
00887517711601 | K161442 | 000 |
00887517711618 | K161442 | 000 |
00887517711625 | K161442 | 000 |
00887517711540 | K161442 | 000 |
00887517711533 | K161442 | 000 |
00887517711526 | K161442 | 000 |
00887517711243 | K161442 | 000 |
00887517711250 | K161442 | 000 |
00887517711267 | K161442 | 000 |
00887517711274 | K161442 | 000 |
00887517711281 | K161442 | 000 |
00887517711298 | K161442 | 000 |
00887517711502 | K161442 | 000 |
00887517711519 | K161442 | 000 |
00887517711632 | K161442 | 000 |
00887517711649 | K161442 | 000 |
00887517711656 | K161442 | 000 |
00887517711779 | K161442 | 000 |
00887517711786 | K161442 | 000 |
00887517711793 | K161442 | 000 |
00887517711809 | K161442 | 000 |
00887517711816 | K161442 | 000 |
00887517711823 | K161442 | 000 |
00887517711830 | K161442 | 000 |
00887517711847 | K161442 | 000 |
00887517711762 | K161442 | 000 |
00887517711755 | K161442 | 000 |
00887517711748 | K161442 | 000 |
00887517711663 | K161442 | 000 |
00887517711670 | K161442 | 000 |
00887517711687 | K161442 | 000 |
00887517711694 | K161442 | 000 |
00887517711700 | K161442 | 000 |
00887517711717 | K161442 | 000 |
00887517711724 | K161442 | 000 |
00887517711731 | K161442 | 000 |
00887517728579 | K161442 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NUVASIVE 76298757 2818737 Live/Registered |
NUVASIVE, INC. 2001-08-10 |
NUVASIVE 75822001 2541247 Live/Registered |
NUVASIVE, INC. 1999-10-13 |