Orthofab, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Orthofab, Inc.” (first 1985, latest 1997), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | 3 | 3 |
| IOR | Wheelchair, Mechanical | 2 | 2 |
| GES | Blade, Scalpel | 1 | 1 |
| KCY | Tourniquet, Pneumatic | 1 | 1 |
Review panels
Most recent Orthofab, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962565 | POWERED WHEELCHAIR | ITI | 1997-03-20 | 262 |
| K952675 | ORTHOFAB WHEELCHAIR | ITI | 1996-05-07 | 330 |
| K950904 | ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) | IOR | 1995-04-05 | 36 |
| K950903 | ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR) | IOR | 1995-04-05 | 36 |
| K884812 | KARMA-RS, KARMA-FS WHEELCHAIRS | ITI | 1988-12-27 | 40 |
| K860095 | DIGIKIT NONPNEUMATIC TOURNIQUET | KCY | 1986-01-24 | 14 |
| K852661 | APOLLO STERILE BLADES | GES | 1985-07-11 | 17 |
Recalls
openFDA lists no recalls under a recalling firm named Orthofab, Inc..
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 Orthofab, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Orthofab, Inc.” (first 1985, latest 1997), across 4 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 Orthofab, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthofab, Inc. is 36 days.
Which FDA product codes appear under Orthofab, Inc.?
The most frequent FDA product codes under this applicant name are ITI (Wheelchair, Powered, 3); IOR (Wheelchair, Mechanical, 2); GES (Blade, Scalpel, 1).
Next steps
- See all 7 Orthofab, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ITI, Orthofab, Inc.'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.