NDK

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

System, External Fixator (With Metallic Invasive Components)

Device class

Class II (moderate risk)

Regulation

21 CFR 888.3040

Medical specialty

Orthopedic

Flags

Implant

Adverse events (MAUDE)

2026: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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