Onyx Medical Corp.: FDA filings under this applicant name
FDA lists 48 510(k) clearances under the applicant name “Onyx Medical Corp.” (first 1990, latest 2004), across 15 product codes in 3 review panels. Median 510(k) review time under this name: 16 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 | 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 14 | 14 |
| HWC | Screw, Fixation, Bone | 11 | 11 |
| JDR | Staple, Fixation, Bone | 3 | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| LXH | Orthopedic Manual Surgical Instrument | 3 | 3 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| JDW | Pin, Fixation, Threaded | 2 | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
Plus 5 more product codes.
Review panels
- Orthopedic (46)
- General Hospital (1)
- Physical Medicine (1)
Most recent Onyx Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041679 | COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT | ILY | 2004-12-16 | 178 |
| K942022 | FACE-IT SHIELD | LYU | 1994-07-08 | 73 |
| K931690 | SPOON PLATE | HRS | 1994-06-07 | 428 |
| K934614 | MINI FRAGMENT PLATE | HRS | 1994-05-04 | 219 |
| K931692 | T-PLATE | HRS | 1994-05-04 | 394 |
| K931684 | EPIPHYSIS PLATE | HRS | 1994-05-04 | 394 |
| K931680 | CANNULATED CANCELLOUS SCREW | HWC | 1994-05-04 | 394 |
| K934616 | CANCELLOUS BONE SCREW | HWC | 1994-04-25 | 210 |
| K934615 | CANCELLOUS BONE SCREW | HWC | 1994-04-25 | 210 |
| K931790 | CORTICAL BONE SCREW | HWC | 1994-04-25 | 378 |
38 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Onyx Medical Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Onyx Industries, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Onyx Medical Corp.?
FDA lists 48 510(k) clearances under the applicant name “Onyx Medical Corp.” (first 1990, latest 2004), across 15 product codes in 3 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 Onyx Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Onyx Medical Corp. is 16 days.
Which FDA product codes appear under Onyx Medical Corp.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 14); HWC (Screw, Fixation, Bone, 11); JDR (Staple, Fixation, Bone, 3).
Next steps
- See all 48 Onyx Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Onyx Medical Corp.'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.