FDA 510(k) Applications Submitted by PRECISION SPINE, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220324 |
02/03/2022 |
AccuFit Lateral 2-Hole Plate |
Precision Spine, Inc. |
| K220862 |
03/24/2022 |
E-GPS Navigated Instruments |
Precision Spine, Inc. |
| K150851 |
03/31/2015 |
Sure Lok Mini Posterior Cervical/Upper Thoracic System |
PRECISION SPINE, INC. |
| K150856 |
03/31/2015 |
Reform Pedicle Screw System |
PRECISION SPINE, INC. |
| K231229 |
04/28/2023 |
S-COMP Reform« POCT Navigation Instruments |
Precision Spine, Inc. |
| K212075 |
07/02/2021 |
ShurFit Lumbar Interbody System |
Precision Spine, Inc. |
| K212937 |
09/15/2021 |
Dakota ALIF Plate System |
Precision Spine, Inc. |
| K213118 |
09/27/2021 |
Dakota ALIF System |
Precision Spine, Inc. |
| K203129 |
10/19/2020 |
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System |
Precision Spine, Inc. |
| K141397 |
05/28/2014 |
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM |
PRECISION SPINE, INC. |
| K160568 |
02/29/2016 |
Precision Spine Interspinous Plate System |
Precision Spine, Inc. |
| K151422 |
05/28/2015 |
Reform Pedicle Screw System |
Precision Spine, Inc. |
| K171657 |
06/05/2017 |
ShurFit 2C Lumbar Interbody Fusion System |
Precision Spine, Inc. |
| K181606 |
06/19/2018 |
Precision Spine Navigation Instrumentation |
Precision Spine, Inc. |
| K161809 |
07/01/2016 |
ShurFit CpTi-HA ACIF Interbody Fusion System |
Precision Spine, Inc. |
| K151863 |
07/08/2015 |
Precision Spine Interspinous Plate System |
PRECISION SPINE, INC. |
| K162211 |
08/08/2016 |
AccuFit Lateral Plate System |
PRECISION SPINE, INC. |
| K162300 |
08/16/2016 |
Reform« POCT System |
PRECISION SPINE, INC. |
| K172495 |
08/18/2017 |
Reform« POCT System |
Precision Spine, Inc. |
| K142378 |
08/26/2014 |
Interspinous Plate System |
Precision Spine, Inc. |
| K173130 |
09/29/2017 |
Reform« Midline Cortical Screw System |
Precision Spine, Inc. |
| K143248 |
11/12/2014 |
Reform Pedicle Screw System |
PRECISION SPINE, INC. |
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