The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Fortress Pedicle Screw System.
Device ID | K140010 |
510k Number | K140010 |
Device Name: | FORTRESS PEDICLE SCREW SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | SPINEOLOGY, INC. 7800 3RD ST NORTH SUITE 600 St. Paul, MN 55128 |
Contact | Karen Roche |
Correspondent | Karen Roche SPINEOLOGY, INC. 7800 3RD ST NORTH SUITE 600 St. Paul, MN 55128 |
Product Code | NKB |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-02 |
Decision Date | 2014-04-23 |
Summary: | summary |