The following data is part of a premarket notification filed by Life Spine with the FDA for Life Spine Cross Connector.
Device ID | K073480 |
510k Number | K073480 |
Device Name: | LIFE SPINE CROSS CONNECTOR |
Classification | Thoracolumbosacral Pedicle Screw System |
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 | 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 | 2007-12-11 |
Decision Date | 2008-01-04 |
Summary: | summary |