Unit, Traction, Hip, Non-powered, Non-penetrating

Device Code: 4473

Product Code(s): HSR

Device Classification Information

Device Type ID4473
Device NameUnit, Traction, Hip, Non-powered, Non-penetrating
Regulation DescriptionNoninvasive Traction Component.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Restorative And Repair Devices Branch (RRDB)
Submission Type510(K) Exempt
CFR Regulation Number888.5890 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHSR
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4473
DeviceUnit, Traction, Hip, Non-powered, Non-penetrating
Product CodeHSR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNoninvasive Traction Component.
CFR Regulation Number888.5890 [🔎]
TPLC Last Update: 2019-04-02 20:50:01

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