Prosthesis, Subtalar, Plug, Polymer

Device Code: 4622

Product Code(s): MJW

Device Classification Information

Device Type ID4622
Device NameProsthesis, Subtalar, Plug, Polymer
Regulation DescriptionSmooth Or Threaded Metallic Bone Fixation Fastener.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Submission Type510(k)
CFR Regulation Number888.3040 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMJW
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4622
DeviceProsthesis, Subtalar, Plug, Polymer
Product CodeMJW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSmooth Or Threaded Metallic Bone Fixation Fastener.
CFR Regulation Number888.3040 [🔎]
Device Problems
Device Dislodged Or Dislocated
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:52:57

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