The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Coroent Small Interlock System.
Device ID | K142299 |
510k Number | K142299 |
Device Name: | CoRoent Small Interlock 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 | 2014-08-18 |
Decision Date | 2014-11-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00887517676757 | K142299 | 000 |
00887517673183 | K142299 | 000 |
00887517673176 | K142299 | 000 |
00887517673169 | K142299 | 000 |
00887517663993 | K142299 | 000 |
00887517663986 | K142299 | 000 |
00887517663979 | K142299 | 000 |
00887517663962 | K142299 | 000 |
00887517663955 | K142299 | 000 |
00887517663948 | K142299 | 000 |
00887517663931 | K142299 | 000 |
00887517663924 | K142299 | 000 |
00887517663917 | K142299 | 000 |
00887517663900 | K142299 | 000 |
00887517673190 | K142299 | 000 |
00887517676603 | K142299 | 000 |
00887517676610 | K142299 | 000 |
00887517676740 | K142299 | 000 |
00887517676733 | K142299 | 000 |
00887517676726 | K142299 | 000 |
00887517676719 | K142299 | 000 |
00887517676702 | K142299 | 000 |
00887517676696 | K142299 | 000 |
00887517676689 | K142299 | 000 |
00887517676672 | K142299 | 000 |
00887517676665 | K142299 | 000 |
00887517676658 | K142299 | 000 |
00887517676641 | K142299 | 000 |
00887517676634 | K142299 | 000 |
00887517676627 | K142299 | 000 |
00887517663894 | K142299 | 000 |