Precision Spine, Inc.: FDA clearances and approvals
Precision Spine, Inc. has 26 FDA 510(k) clearances (first 2014, latest 2025), across 11 product codes in 1 review panel. Median 510(k) review time: 92 days. Since 2017 its median was 103 days, against 90 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 3 | 37 |
| 2015 | 4 | 75 |
| 2016 | 4 | 105 |
| 2017 | 2 | 74 |
| 2018 | 1 | 236 |
| 2019 | 2 | 256 |
| 2020 | 1 | 103 |
| 2021 | 3 | 85 |
| 2022 | 3 | 112 |
| 2023 | 1 | 27 |
| 2024 | 1 | 137 |
| 2025 | 1 | 256 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Precision Spine, Inc.'s cleared 510(k)s took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 6 | 6 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 | 4 |
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
| PEK | Spinous Process Plate | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| NKG | Posterior Cervical Screw System | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (26)
Most recent Precision Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250769 | Dakota LP System | ODP | 2025-11-24 | 256 |
| K242297 | Reform Pedicle Screw System | NKB | 2024-12-17 | 137 |
| K231229 | S-COMP Reform® POCT Navigation Instruments | OLO | 2023-05-25 | 27 |
| K220862 | E-GPS Navigated Instruments | OLO | 2022-07-14 | 112 |
| K213118 | Dakota ALIF System | OVD | 2022-04-01 | 186 |
| K220324 | AccuFit Lateral 2-Hole Plate | KWQ | 2022-03-16 | 41 |
| K212075 | ShurFit Lumbar Interbody System | MAX | 2021-12-08 | 159 |
| K212937 | Dakota ALIF Plate System | KWQ | 2021-11-04 | 50 |
| K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System | OVE | 2021-01-12 | 85 |
| K200303 | Reform Pedicle Screw System | NKB | 2020-05-19 | 103 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Precision Spine, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Precision Spine, Inc. have?
Precision Spine, Inc. has 26 FDA 510(k) clearances (first 2014, latest 2025), across 11 product codes in 1 review panel.
How long does FDA take to clear Precision Spine, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Precision Spine, Inc.'s cleared 510(k)s is 92 days. Since 2017: 103 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Precision Spine, Inc. make?
Its most frequent FDA product codes are NKB (Thoracolumbosacral Pedicle Screw System, 6); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 4); OLO (Orthopedic Stereotaxic Instrument, 3).
Has Precision Spine, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Precision Spine, Inc. Related entities may recall under other names.
Next steps
- See all 26 Precision Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Precision Spine, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.