Wiltrom Corporation Limited: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Wiltrom Corporation Limited” (first 2012, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 192 days. Since 2017 the median was 167 days, against 78 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 | 1 | 533 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 3 | 192 |
| 2019 | 0 | — |
| 2020 | 1 | 25 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wiltrom Corporation Limited took a median 167 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 78 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
Review panels
- Orthopedic (5)
Most recent Wiltrom Corporation Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202894 | Wiltrom Spinal Fixation System | NKB | 2020-10-23 | 25 |
| K180758 | Osteocera Resorbable Bone Substitute | MQV | 2018-10-24 | 216 |
| K172237 | Bicera Resorbable Bone Substitute | MQV | 2018-02-02 | 192 |
| K172548 | Wiltrom Spinal Fixation System | NKB | 2018-01-12 | 142 |
| K110949 | BICERA (TM) RESORBABLE BONE SUBSTITUTE | MQV | 2012-09-18 | 533 |
Recalls
openFDA lists no recalls under a recalling firm named Wiltrom Corporation Limited.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Wiltrom Corporation Limited?
FDA lists 5 510(k) clearances under the applicant name “Wiltrom Corporation Limited” (first 2012, latest 2020), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wiltrom Corporation Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wiltrom Corporation Limited is 192 days. Since 2017: 167 days, versus 78 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wiltrom Corporation Limited?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 3); NKB (Thoracolumbosacral Pedicle Screw System, 2).
Next steps
- See all 5 Wiltrom Corporation Limited clearances with predicates and recalls
- Run predicate analysis for product code MQV, Wiltrom Corporation Limited'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.