Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Precision Spine, Inc. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
236 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250769 | Dakota LP System | Precision Spine, Inc. | 2025-11-24 | 256 | 0 |
| K242297 | Reform Pedicle Screw System | Precision Spine, Inc. | 2024-12-17 | 137 | 0 |
| K231229 | S-COMP Reform® POCT Navigation Instruments | Precision Spine, Inc. | 2023-05-25 | 27 | 0 |
| K220862 | E-GPS Navigated Instruments | Precision Spine, Inc. | 2022-07-14 | 112 | 0 |
| K213118 | Dakota ALIF System | Precision Spine, Inc. | 2022-04-01 | 186 | 0 |
| K220324 | AccuFit Lateral 2-Hole Plate | Precision Spine, Inc. | 2022-03-16 | 41 | 0 |
| K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | 2021-12-08 | 159 | 0 |
| K212937 | Dakota ALIF Plate System | Precision Spine, Inc. | 2021-11-04 | 50 | 0 |
| K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (A | Precision Spine, Inc. | 2021-01-12 | 85 | 0 |
| K181606 | Precision Spine Navigation Instrumentation | Precision Spine, Inc. | 2019-09-27 | 465 | 0 |
| K172495 | Reform® POCT System | Precision Spine, Inc. | 2018-04-11 | 236 | 0 |
| K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017-12-19 | 81 | 0 |
| K171657 | ShurFit 2C Lumbar Interbody Fusion System | Precision Spine, Inc. | 2017-08-11 | 67 | 0 |
| K161809 | ShurFit CpTi-HA ACIF Interbody Fusion System | Precision Spine, Inc. | 2016-12-06 | 158 | 0 |
| K162211 | AccuFit Lateral Plate System | Precision Spine, Inc. | 2016-11-28 | 112 | 0 |
| K162300 | Reform® POCT System | Precision Spine, Inc. | 2016-11-22 | 98 | 0 |
| K160568 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | 2016-05-04 | 65 | 0 |
| K151422 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015-08-21 | 85 | 0 |
| K151863 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | 2015-08-07 | 30 | 0 |
| K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015-07-07 | 98 | 0 |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | Precision Spine, Inc. | 2015-06-04 | 65 | 0 |
| K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014-12-19 | 37 | 0 |
| K142378 | Interspinous Plate System | Precision Spine, Inc. | 2014-12-18 | 114 | 0 |
| K141397 | SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM | Precision Spine, Inc. | 2014-06-26 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda