Data / Medical devices / Saw, Pneumatically Powered
Saw, Pneumatically Powered (KFK): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Saw, Pneumatically Powered (product code KFK, Class 1, 21 CFR 878.4820). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on August 7, 1989, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- KFK
- Device class
- 1
- Regulation
- 878.4820
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Germany | 2 |
| Mexico | 1 |
Makers of Saw, Pneumatically Powered
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Linvatec Corporation | Largo, FL, United States | Manufacturer | 1 | August 20, 1980 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Powered Surgical Solutions | Fort Worth, TX, United States | Manufacturer, Specification developer | 1 | February 24, 1987 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brasseler U.S.A. Medical, LLC | Savannah, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heinrich Medizintechnik GMBH | Stuttgart Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 7, 1989. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.