The following data is part of a premarket notification filed by Centinel Spine, Inc. with the FDA for Stalif Cti, Stalif C.
Device ID | K142079 |
510k Number | K142079 |
Device Name: | STALIF CTI, STALIF C |
Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
Applicant | CENTINEL SPINE, INC. 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
Contact | Justin Eggleton |
Correspondent | Justin Eggleton CENTINEL SPINE, INC. 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
Product Code | OVE |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-31 |
Decision Date | 2014-10-24 |
Summary: | summary |