Splint, Traction

Device Code: 4471

Product Code(s): HSP

Device Classification Information

Device Type ID4471
Device NameSplint, Traction
Regulation DescriptionNoninvasive Traction Component.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type510(K) Exempt
CFR Regulation Number888.5890 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHSP
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4471
DeviceSplint, Traction
Product CodeHSP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNoninvasive Traction Component.
CFR Regulation Number888.5890 [🔎]
TPLC Last Update: 2019-04-02 20:49:59

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