The following data is part of a premarket notification filed by Life Spine with the FDA for Life Spine Lumbar Plate System.
Device ID | K093200 |
510k Number | K093200 |
Device Name: | LIFE SPINE LUMBAR PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
Contact | Charles Gill |
Correspondent | Charles Gill 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 | 2009-10-09 |
Decision Date | 2010-01-19 |
Summary: | summary |