Data / Medical devices / Table, Operating-Room, Pneumatic
Table, Operating-Room, Pneumatic (FWW): 9 FDA-registered makers in 6 countries
9 establishments in 6 countries are registered with the FDA to make Table, Operating-Room, Pneumatic (product code FWW, Class 1, 21 CFR 878.4960). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on November 29, 1995, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- FWW
- Device class
- 1
- Regulation
- 878.4960
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Colombia | 1 |
| China | 1 |
| Netherlands | 1 |
| India | 1 |
| Mexico | 1 |
Makers of Table, Operating-Room, Pneumatic
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 |
|---|---|---|---|---|---|---|---|---|
| Alphatec Spine, Inc. | Carlsbad, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphatec Spine, Inc. | Memphis, TN, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Metalicas Los Pinos SA | ITAGUI Antioquia, Colombia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Sintang Health&technology Co.,ltd | Yancheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Soteria Medical B.V. | Arnhem Gelderland, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Poly Engineering Pvt. Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wear Tex S. De R.L. De C.V. | Torreon Coahuila, Mexico | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 29, 1995. 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.