The following data is part of a premarket notification filed by Life Spine with the FDA for Kinetic Anterior Cervical Plate.
Device ID | K062643 |
510k Number | K062643 |
Device Name: | KINETIC ANTERIOR CERVICAL PLATE |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | LIFE SPINE 2400 HASSELL ROAD SUITE 370 Hoffman Estates, IL 60169 |
Contact | Erin Malloy |
Correspondent | Erin Malloy LIFE SPINE 2400 HASSELL ROAD SUITE 370 Hoffman Estates, IL 60169 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-06 |
Decision Date | 2006-11-16 |
Summary: | summary |