Orthopedic Equipment Co., Inc.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Orthopedic Equipment Co., Inc.” (first 1976, latest 1984), across 31 product codes in 5 review panels. Median 510(k) review time under this name: 20 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 |
|---|---|---|---|
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 6 | 6 |
| KNO | Accessories, Wheelchair | 4 | 4 |
| GEN | Forceps, General & Plastic Surgery | 3 | 3 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| FSA | Lift, Patient, Non-Ac-Powered | 1 | 1 |
| GAD | Retractor | 1 | 1 |
| GAZ | Tubing, Noninvasive | 1 | 1 |
| GEG | Elevator, Surgical, General & Plastic Surgery | 1 | 1 |
Plus 21 more product codes.
Review panels
- Orthopedic (18)
- Physical Medicine (10)
- General and Plastic Surgery (10)
- General Hospital (3)
- Neurology (1)
Most recent Orthopedic Equipment Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K834035 | UNIVERSAL SELF-ALIGNING ACETABULAR COM | JDI | 1984-06-19 | 209 |
| K841189 | OEC/REZAIAN SPINAL FIXATOR | KWQ | 1984-05-16 | 57 |
| K800530 | SCHLEIN TRI-SURFACE ANKLE | HSN | 1980-04-02 | 26 |
| K781445 | SPREADER | GAD | 1979-09-27 | 400 |
| K790247 | TOURNIQUET TEST GAGE | — | 1979-02-26 | 20 |
| K790209 | FILTER SYSTEM, ALTNER DISPOSABLE | GAZ | 1979-02-26 | 27 |
| K781451 | FLAT WRENCH | HXS | 1978-09-27 | 35 |
| K781450 | DRIVERS | GFC | 1978-09-27 | 35 |
| K781449 | HARRINGTON SPINAL ELEVATOR | GEG | 1978-09-27 | 35 |
| K781448 | HARRINGTON HOOK CLAMP | GEN | 1978-09-27 | 35 |
35 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orthopedic Equipment Co., 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.
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.
- Orthopedic Systems, Inc. (95 510(k)s)
- Orthopedic Sciences, Inc. (11 510(k)s)
- Orthopedic Designs, Inc. (4 510(k)s)
- Orthopedic Designs North America, Inc. (4 510(k)s)
- Orthopedic Alliance, LLC (3 510(k)s)
- Orthopedic Source, Inc. (3 510(k)s)
- Orthopedic Development, Inc. (2 510(k)s)
- Orthopedic Technology, Inc. (2 510(k)s)
- Orthopedic Technology Research, Inc. (2 510(k)s)
- Orthopedic Designs, Inc. (Odi) (1 510(k)s)
- Orthopedic Designs North America, Inc. (Odi-Na) (1 510(k)s)
- Orthopedic Driven Imaging, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthopedic Equipment Co., Inc.?
FDA lists 45 510(k) clearances under the applicant name “Orthopedic Equipment Co., Inc.” (first 1976, latest 1984), across 31 product codes in 5 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 Orthopedic Equipment Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthopedic Equipment Co., Inc. is 20 days.
Which FDA product codes appear under Orthopedic Equipment Co., Inc.?
The most frequent FDA product codes under this applicant name are JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal, 6); KNO (Accessories, Wheelchair, 4); GEN (Forceps, General & Plastic Surgery, 3).
Next steps
- See all 45 Orthopedic Equipment Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDG, Orthopedic Equipment Co., 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.