Pylon, Post Surgical

Device Code: 5176

Product Code(s): ISM

Device Classification Information

Device Type ID5176
Device NamePylon, Post Surgical
Regulation DescriptionProsthetic And Orthotic Accessory.
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 Number890.3025 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeISM
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5176
DevicePylon, Post Surgical
Product CodeISM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionProsthetic And Orthotic Accessory.
CFR Regulation Number890.3025 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
MED-EL Elektromedizinische Gereate, Gmbh
II Mar-02-2017
TPLC Last Update: 2019-04-02 21:01:36

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