Protractor

Device Code: 4476

Product Code(s): HTH

Device Classification Information

Device Type ID4476
Device NameProtractor
Regulation DescriptionProtractor For Clinical Use.
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 Number888.4600 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHTH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4476
DeviceProtractor
Product CodeHTH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionProtractor For Clinical Use.
CFR Regulation Number888.4600 [🔎]
TPLC Last Update: 2019-04-02 20:50:04

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