The following data is part of a premarket notification filed by Centinel Spine, Inc. with the FDA for Centinel Spine Stalif Tt, Stalif Midline, Midline Ii, Midline Ii-ti.
| Device ID | K150643 |
| 510k Number | K150643 |
| Device Name: | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | CENTINEL SPINE, INC. 900 AIRPORT ROAD, SUITE 3B West Chester, PA 19380 |
| Contact | Mr. John Parry |
| Correspondent | Mr. Justin Eggleton MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS, LLC 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-12 |
| Decision Date | 2015-06-08 |
| Summary: | summary |