Universal Prosthetics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Universal Prosthetics, Inc. makes
Universal Prosthetics, Inc. manufactures medical devices for facial and laryngeal reconstruction, including the Zoller Burned Lip Conformer for lip reshaping after burns, the Northwestern Voice Restoration Kit for speech rehabilitation, and The Chicago Gullet, a prosthetic for esophageal reconstruction.
These devices are regulated under FDA Class I and Class II classifications, with authorisation primarily through the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Zoller Burned Lip Conformer Ref K832366
510(k) 510(k)Northwestern Voice Restoration Kit Ref K811428
510(k) 510(k)The Chicago Gullet Ref K813132
510(k) 510(k)
Frequently asked questions
How many devices does Universal Prosthetics, Inc. have in the registry?
The registry currently lists 3 devices for Universal Prosthetics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Universal Prosthetics, Inc.'s devices?
Among its 3 most recently registered devices, Universal Prosthetics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Universal Prosthetics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Universal Prosthetics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Universal Prosthetics, Inc. in the registry?
The most recently registered devices listed for Universal Prosthetics, Inc. include ZOLLER BURNED LIP CONFORMER, NORTHWESTERN VOICE RESTORATION KIT and THE CHICAGO GULLET.