Wire, Fixation, Intraosseous

Device Code: 1105

Product Code(s): DZK

Device Classification Information

Device Type ID1105
Device NameWire, Fixation, Intraosseous
Regulation DescriptionIntraosseous Fixation Screw Or Wire.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(k)
CFR Regulation Number872.4880 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDZK
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1105
DeviceWire, Fixation, Intraosseous
Product CodeDZK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionIntraosseous Fixation Screw Or Wire.
CFR Regulation Number872.4880 [🔎]
Device Problems
Break
1
Insufficient Information
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 19:48:27

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