Cage, Knee

Device Code: 5189

Product Code(s): ITM

Device Classification Information

Device Type ID5189
Device NameCage, Knee
Regulation DescriptionLimb Orthosis.
Regulation Medical SpecialtyPhysical Medicine
Review PanelPhysical Medicine
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission Type510(K) Exempt
CFR Regulation Number890.3475 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeITM
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5189
DeviceCage, Knee
Product CodeITM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLimb Orthosis.
CFR Regulation Number890.3475 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
2
Patient-Device Incompatibility
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 21:01:53

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.