Weigao Orthopaedic Device Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Weigao Orthopaedic Device Co., Ltd.” (first 2012, latest 2014), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 176 days. 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 | 176 |
| 2013 | 3 | 73 |
| 2014 | 1 | 291 |
| 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Weigao Orthopaedic Device Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133053 | MILESTONE SPINAL SYSTEM | MAX | 2014-07-15 | 291 |
| K122994 | INTRAMEDULLARY NAIL SYSTEM | MNH | 2013-04-12 | 197 |
| K130340 | LOCKING BONE PLATES AND SCREWS | HRS | 2013-04-05 | 53 |
| K123578 | ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2013-02-01 | 73 |
| K121312 | INTRAMEDULLARY NAIL SYSTEM | HSB | 2012-10-24 | 176 |
Recalls
openFDA lists no recalls under a recalling firm named Weigao Orthopaedic Device Co., Ltd..
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 Weigao Orthopaedic Device Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Weigao Orthopaedic Device Co., Ltd.” (first 2012, latest 2014), across 5 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 Weigao Orthopaedic Device Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Weigao Orthopaedic Device Co., Ltd. is 176 days.
Which FDA product codes appear under Weigao Orthopaedic Device Co., Ltd.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 1); HSB (Rod, Fixation, Intramedullary And Accessories, 1); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1).
Next steps
- See all 5 Weigao Orthopaedic Device Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Weigao Orthopaedic Device Co., Ltd.'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.