The following data is part of a premarket notification filed by Centinel Spine, Inc. with the FDA for Stalif C; Stalif C-ti.
| Device ID | K150053 |
| 510k Number | K150053 |
| Device Name: | STALIF C; STALIF C-Ti |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Centinel Spine, Inc. 900 Airport Road, Suite 3B West Chester, PA 19380 |
| Contact | John Parry |
| Correspondent | Justin Eggleton MCRA, LLC 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 | 2015-01-12 |
| Decision Date | 2015-06-24 |
| Summary: | summary |