Us Spine: FDA clearances and approvals
Us Spine has 5 FDA 510(k) clearances (first 2006, latest 2008), across 4 product codes in 1 review panel. Median 510(k) review time: 84 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Us Spine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082801 | PHANTOM PLUS CAGE SYSTEM | ODP | 2008-12-22 | 89 |
| K081883 | MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM | MNH | 2008-09-24 | 84 |
| K081296 | PREFERENCE PEDICLE SCREW SYSTEM | MNH | 2008-06-06 | 30 |
| K062785 | LTD POLYAXIAL FIXATION SYSTEM | KWP | 2006-12-26 | 99 |
| K061041 | US SPINE FACET FIXATION SYSTEM | MRW | 2006-06-19 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named Us Spine.
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 Us Spine have?
Us Spine has 5 FDA 510(k) clearances (first 2006, latest 2008), across 4 product codes in 1 review panel.
How long does FDA take to clear Us Spine's 510(k)s?
The median time from FDA receipt to decision across Us Spine's cleared 510(k)s is 84 days.
What devices does Us Spine make?
Its most frequent FDA product codes are MNH (Orthosis, Spondylolisthesis Spinal Fixation, 2); KWP (Appliance, Fixation, Spinal Interlaminal, 1); MRW (System, Facet Screw Spinal Device, 1).
Has Us Spine had device recalls?
openFDA lists no recalls under a recalling firm name matching Us Spine. Related entities may recall under other names.
Next steps
- See all 5 Us Spine clearances with predicates and recalls
- Run predicate analysis for product code MNH, Us Spine'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.