Lossing Orthopedic, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Lossing Orthopedic, Inc.” (first 1980, latest 1990), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| HST | Apparatus, Traction, Non-Powered | 3 | 3 |
| ION | Exerciser, Non-Measuring | 2 | 2 |
| ITH | Equipment, Traction, Powered | 2 | 2 |
| ILK | Transport, Patient, Powered | 1 | 1 |
Review panels
- Physical Medicine (5)
- Neurology (3)
Most recent Lossing Orthopedic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900475 | DISTRAC(TM) TABLE | ITH | 1990-05-24 | 112 |
| K864152 | BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE | ILK | 1987-02-05 | 105 |
| K862874 | THE TOWERED 90/90 UNIT | HST | 1986-08-07 | 8 |
| K843581 | PROM NAID | ITH | 1984-12-11 | 91 |
| K840551 | MOBILIZER | ION | 1984-03-23 | 44 |
| K823236 | BACK ON TRACK INVERSION THERAPY & EXER | ION | 1983-01-21 | 81 |
| K813017 | NECKTRAC | HST | 1981-11-25 | 29 |
| K802555 | COTTRELL 90/90 BACKTRAC | HST | 1980-10-31 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Lossing Orthopedic, 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 Lossing Orthopedic, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Lossing Orthopedic, Inc.” (first 1980, latest 1990), 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 Lossing Orthopedic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lossing Orthopedic, Inc. is 62 days.
Which FDA product codes appear under Lossing Orthopedic, Inc.?
The most frequent FDA product codes under this applicant name are HST (Apparatus, Traction, Non-Powered, 3); ION (Exerciser, Non-Measuring, 2); ITH (Equipment, Traction, Powered, 2).
Next steps
- See all 8 Lossing Orthopedic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HST, Lossing Orthopedic, 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.