Atlas FDA

HXS

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Twister, Wire
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Medical specialty
Orthopedic
Adverse events (MAUDE)
1997: 1 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
KLEIN WIRE TIGHTENER/BIONIC WIRE (K833726)Bionic Instrument Corp.1983-12-22
FLAT WRENCH (K781451)Orthopedic Equipment Co., Inc.1978-09-27

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