Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Precision Spine, Inc. with 26 510(k) clearances. The most recent is a 510(k) clearance dated Nov 24, 2025: Dakota LP System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 24, 2025 | Dakota LP SystemK250769 · ODP | 510(k) clearances |
| Dec 17, 2024 | Reform Pedicle Screw SystemK242297 · NKB | 510(k) clearances |
| May 25, 2023 | S-COMP Reform® POCT Navigation InstrumentsK231229 · OLO | 510(k) clearances |
| Jul 14, 2022 | E-GPS Navigated InstrumentsK220862 · OLO | 510(k) clearances |
| Apr 1, 2022 | Dakota ALIF SystemK213118 · OVD | 510(k) clearances |
| Mar 16, 2022 | AccuFit Lateral 2-Hole PlateK220324 · KWQ | 510(k) clearances |
| Dec 8, 2021 | ShurFit Lumbar Interbody SystemK212075 · MAX | 510(k) clearances |
| Nov 4, 2021 | Dakota ALIF Plate SystemK212937 · KWQ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
