U&I Corporation: FDA filings under this applicant name
FDA lists 35 510(k) clearances under 2 spellings of the applicant name “U&I Corporation” (first 2005, latest 2022), across 14 product codes in 2 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 93 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 127 |
| 2013 | 3 | 140 |
| 2014 | 4 | 146 |
| 2015 | 3 | 89 |
| 2016 | 1 | 26 |
| 2017 | 4 | 67 |
| 2018 | 6 | 110 |
| 2019 | 3 | 21 |
| 2020 | 0 | — |
| 2021 | 1 | 266 |
| 2022 | 1 | 28 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name U&I Corporation took a median 93 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 7 | 7 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 6 | 6 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| NKG | Posterior Cervical Screw System | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Plus 4 more product codes.
Review panels
Most recent U&I Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220147 | Aspiron S ACP System | KWQ | 2022-02-16 | 28 |
| K210573 | Velofix SA Cervical Cage | OVE | 2021-11-19 | 266 |
| K183243 | Velofix TLIF Cage | MAX | 2019-07-10 | 231 |
| K190067 | Velofix Interbody Fusion System | ODP | 2019-02-04 | 20 |
| K190053 | SECULOK ACP System | KWQ | 2019-02-01 | 21 |
| K181824 | CBT Screw Fixation System | NKB | 2018-12-13 | 157 |
| K183383 | ANAX OCT Spinal System | NKG | 2018-12-12 | 6 |
| K181829 | Velofix TLIF Cage | MAX | 2018-11-14 | 128 |
| K182055 | SECULOK ACP System | KWQ | 2018-09-10 | 41 |
| K180759 | SECULOK Suture Anchor | MBI | 2018-08-09 | 140 |
25 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2020-05-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- U&I Corporation (23)
- U&I Corp. (12)
Frequently asked questions
How many FDA 510(k) clearances are listed under U&I Corporation?
FDA lists 35 510(k) clearances under 2 spellings of the applicant name “U&I Corporation” (first 2005, latest 2022), across 14 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by U&I Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name U&I Corporation is 116 days. Since 2017: 93 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under U&I Corporation?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 7); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 6); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 4).
Next steps
- See all 35 U&I Corporation clearances with predicates and recalls
- Run predicate analysis for product code KWQ, U&I Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.