NOV

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Anchor, Suture, Bone Fixation, Metallic

Device class

Class II (moderate risk)

Regulation

21 CFR 888.3030

Medical specialty

Orthopedic

Flags

Implant

FDA definition

This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim.

Adverse events (MAUDE)

2005: 2 · 2007: 4 · 2008: 4 · 2009: 3 · 2010: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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