The following data is part of a premarket notification filed by Spinal Usa with the FDA for Slimplicity Anterior Cervical Plate System.
Device ID | K060025 |
510k Number | K060025 |
Device Name: | SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | SPINAL USA 213 EASTSIDE LANE Brandon, MS 39047 |
Contact | Jeffrey Johnson |
Correspondent | Jeffrey Johnson SPINAL USA 213 EASTSIDE LANE Brandon, MS 39047 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-04 |
Decision Date | 2006-04-18 |
Summary: | summary |