Prosthesis, Tendon, Passive

Device Code: 4503

Product Code(s): HXA

Device Classification Information

Device Type ID4503
Device NameProsthesis, Tendon, Passive
Regulation DescriptionPassive Tendon 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 Number888.3025 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHXA
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4503
DeviceProsthesis, Tendon, Passive
Product CodeHXA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPassive Tendon Prosthesis.
CFR Regulation Number888.3025 [🔎]
Device Problems
Device Expiration Issue
1
Adverse Event Without Identified Device Or Use Problem
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 20:50:38

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