Company · US
Precision Spine, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2025. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 6 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 |
| OLO | Orthopedic Stereotaxic Instrument | 3 |
| PEK | Spinous Process Plate | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 |
| NKG | Posterior Cervical Screw System | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 24, 2025 | K250769 | Dakota LP System Precision Spine, Inc. | ODP |
| Dec 17, 2024 | K242297 | Reform Pedicle Screw System Precision Spine, Inc. | NKB |
| May 25, 2023 | K231229 | S-COMP Reform® POCT Navigation Instruments Precision Spine, Inc. | OLO |
| Jul 14, 2022 | K220862 | E-GPS Navigated Instruments Precision Spine, Inc. | OLO |
| Apr 1, 2022 | K213118 | Dakota ALIF System Precision Spine, Inc. | OVD |
| Mar 16, 2022 | K220324 | AccuFit Lateral 2-Hole Plate Precision Spine, Inc. | KWQ |
| Dec 8, 2021 | K212075 | ShurFit Lumbar Interbody System Precision Spine, Inc. | MAX |
| Nov 4, 2021 | K212937 | Dakota ALIF Plate System Precision Spine, Inc. | KWQ |
| Jan 12, 2021 | K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System Precision Spine, Inc. | OVE |
| May 19, 2020 | K200303 | Reform Pedicle Screw System Precision Spine | NKB |
| Oct 29, 2019 | K192494 | NexGen Anterior Cervical Plate System Precision Spine | KWQ |
| Sep 27, 2019 | K181606 | Precision Spine Navigation Instrumentation Precision Spine, Inc. | OLO |
| Apr 11, 2018 | K172495 | Reform® POCT System Precision Spine, Inc. | NKG |
| Dec 19, 2017 | K173130 | Reform® Midline Cortical Screw System Precision Spine, Inc. | NKB |
| Aug 11, 2017 | K171657 | ShurFit 2C Lumbar Interbody Fusion System Precision Spine, Inc. | MAX |
| Dec 6, 2016 | K161809 | ShurFit CpTi-HA ACIF Interbody Fusion System Precision Spine, Inc. | ODP |
| Nov 28, 2016 | K162211 | AccuFit Lateral Plate System Precision Spine, Inc. | KWQ |
| Nov 22, 2016 | K162300 | Reform® POCT System Precision Spine, Inc. | NKG |
| May 4, 2016 | K160568 | Precision Spine Interspinous Plate System Precision Spine, Inc. | PEK |
| Aug 21, 2015 | K151422 | Reform Pedicle Screw System Precision Spine, Inc. | NKB |
| Aug 7, 2015 | K151863 | Precision Spine Interspinous Plate System Precision Spine, Inc. | PEK |
| Jul 7, 2015 | K150856 | Reform Pedicle Screw System Precision Spine, Inc. | NKB |
| Jun 4, 2015 | K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic System Precision Spine, Inc. | KWP |
| Dec 19, 2014 | K143248 | Reform Pedicle Screw System Precision Spine, Inc. | NKB |
| Dec 18, 2014 | K142378 | Interspinous Plate System Precision Spine, Inc. | PEK |
| Jun 26, 2014 | K141397 | SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM Precision Spine, Inc. | MNI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||