Prosthesis, Wrist, Carpal Lunate

Device Code: 4572

Product Code(s): KWN

Device Classification Information

Device Type ID4572
Device NameProsthesis, Wrist, Carpal Lunate
Regulation DescriptionWrist Joint Carpal Lunate Polymer Prosthesis.
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)
CFR Regulation Number888.3750 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKWN
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4572
DeviceProsthesis, Wrist, Carpal Lunate
Product CodeKWN
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionWrist Joint Carpal Lunate Polymer Prosthesis.
CFR Regulation Number888.3750 [🔎]
Premarket Reviews
ManufacturerDecision
ARTHROCARE CORP.
 
SUBSTANTIALLY EQUIVALENT
1
ARTHROSURFACE, INC.
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Insufficient Information
2
Migration Or Expulsion Of Device
2
Inadequacy Of Device Shape And/or Size
1
Total Device Problems 5
TPLC Last Update: 2019-04-02 20:51:58

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