The following data is part of a premarket notification filed by Centinel Spine with the FDA for Stalif Midline.
| Device ID | K101301 |
| 510k Number | K101301 |
| Device Name: | STALIF MIDLINE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | CENTINEL SPINE 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton CENTINEL SPINE 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-10 |
| Decision Date | 2010-09-24 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STALIF MIDLINE 77874913 4003160 Live/Registered |
CENTINEL SPINE, LLC 2009-11-17 |