The following data is part of a premarket notification filed by Life Spine with the FDA for Conquest Spinal System.
Device ID | K080767 |
510k Number | K080767 |
Device Name: | CONQUEST SPINAL SYSTEM |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
Contact | Rebecca M Brooks |
Correspondent | Rebecca M Brooks LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-18 |
Decision Date | 2008-05-21 |
Summary: | summary |