FDA 510(k) Applications Submitted by Manthan Damani
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210574 |
02/26/2021 |
NuVasive Pulse System |
NuVasive, Incorporated |
| K142504 |
09/05/2014 |
SpineFrontier Lumbar Interbody Fusion Device System |
SpineFrontier, Inc. |
| K192435 |
09/05/2019 |
NuVasive NuvaLine |
NuVasive, Incorporated |
| K213682 |
11/22/2021 |
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, A |
Edwards Lifesciences, LLC |
| K150017 |
01/05/2015 |
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System |
SpineFrontier, Inc. |
| K151198 |
05/05/2015 |
A-CIFT SoloFuse |
SPINEFRONTIER, INC. |
| K143377 |
11/25/2014 |
PedFuse Pedicle Screw System |
SPINEFRONTIER, INC. |
| K210439 |
02/12/2021 |
NuVasive MOD-EX XLIF Interbody System |
NuVasive, Incorporated |
| K170800 |
03/17/2017 |
NuVasive LessRay with Enhanced Tracking |
NuVasive, Incorporated |
| K171791 |
06/16/2017 |
MAGEC« System |
NuVasive Specialized Orthopedics, Incorporated |
| K172623 |
09/01/2017 |
NuVasive Navigation Instruments |
NuVasive, Incorporated |
| K173314 |
10/19/2017 |
LessRay System |
NuVasive, Incorporated |
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