The following data is part of a premarket notification filed by Life Spine with the FDA for Nautilus Spinal System.
Device ID | K111953 |
510k Number | K111953 |
Device Name: | NAUTILUS SPINAL SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
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 | NKB |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-11 |
Decision Date | 2012-08-07 |
Summary: | summary |