Warsaw Orthopedic, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Warsaw Orthopedic, Inc.” (first 1983, latest 1989), across 17 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 6 | 6 |
| HWR | Driver, Prosthesis | 2 | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 2 |
| FNJ | Bed, Manual | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| HTO | Reamer | 1 | 1 |
| HTP | File | 1 | 1 |
| HWB | Extractor | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Plus 7 more product codes.
Review panels
- Orthopedic (22)
- General Hospital (1)
Most recent Warsaw Orthopedic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K892877 | CRADLE, HOSPITAL BED CLOTHING | FNJ | 1989-06-15 | 57 |
| K883784 | TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE | LYQ | 1989-04-06 | 212 |
| K883783 | TSRH SACRAL SPINAL SCREW | KWP | 1989-04-06 | 212 |
| K880212 | TSRH H/M HOOK HOLDER W/ROD MOVER | KWP | 1988-03-04 | 45 |
| K880211 | TSRH H/M HOOK HOLDER | KWP | 1988-03-04 | 45 |
| K880215 | TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD | KWP | 1988-02-18 | 30 |
| K880214 | TSRH H/M TORQUE LIMITING WRENCH | KWP | 1988-02-18 | 30 |
| K870843 | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | HWT | 1987-05-27 | 85 |
| K870842 | SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP | HTP | 1987-05-27 | 85 |
| K870830 | WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM | KWP | 1987-05-04 | 62 |
14 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2005-06-20.
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 Warsaw Orthopedic, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Warsaw Orthopedic, Inc.” (first 1983, latest 1989), across 17 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 Warsaw Orthopedic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Warsaw Orthopedic, Inc. is 36 days.
Which FDA product codes appear under Warsaw Orthopedic, Inc.?
The most frequent FDA product codes under this applicant name are KWP (Appliance, Fixation, Spinal Interlaminal, 6); HWR (Driver, Prosthesis, 2); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 2).
Next steps
- See all 24 Warsaw Orthopedic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWP, Warsaw 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.