GFC

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Driver, Surgical, Pin

Device class

Class I (low risk)

Regulation

21 CFR 878.4820

Medical specialty

General, Plastic Surgery

Adverse events (MAUDE)

2001: 1 · 2002: 1 · 2004: 2 · 2006: 3 · 2010: 3 · 2016: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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