KWO

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Prosthesis, Wrist, Carpal Scaphoid

Device class

Class II (moderate risk)

Regulation

21 CFR 888.3760

Medical specialty

Orthopedic

Flags

Implant

Adverse events (MAUDE)

2004: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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