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ManoFX Right
Manamed, Inc. · Model ManoFX-R · UDI-DI 00810113683201
10
510(k) clearances
48
Adverse events
1
Recalls
428
Facilities
Description
The ManoFX is a wrist hand finger orthosis. The unique design allows fractures of the hand and finger to be positioned for optimum healing. This innovative approach allows customization of the brace to be configured as a Boxer's fracture splint (ulnar gutter splint), Radial Gutter splint, or a Buddy finger splint (metacarpal fracture brace). Features: Malleable aluminum stays Split dorsal stay Soft breathable body Wraparound design for customized fit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-18 | North Coast Medical Inc | The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.