The following data is part of a premarket notification filed by Life Spine with the FDA for Mis Anterior Cervical Plating System.
Device ID | K103423 |
510k Number | K103423 |
Device Name: | MIS ANTERIOR CERVICAL PLATING SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
Contact | Randy Lewis |
Correspondent | Randy Lewis LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-22 |
Decision Date | 2011-06-01 |
Summary: | summary |