The following data is part of a premarket notification filed by Osso Surgical with the FDA for Fortezza Spinal Stabilization System.
Device ID | K162576 |
510k Number | K162576 |
Device Name: | FORTEZZA Spinal Stabilization System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | OSSO SURGICAL 2150 W 43RD ST Chicago, IL 60609 |
Contact | Basheer Hassan |
Correspondent | Kimberly Strohkirch MRC-X, LLC 3416 ROXEE RUN COVE Bartlett, TN 38133 |
Product Code | NKB |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
Subsequent Product Code | OSH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-09-15 |
Decision Date | 2016-11-10 |
Summary: | summary |