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 |