Skid, Bone

Device Code: 4496

Product Code(s): HWO

Device Classification Information

Device Type ID4496
Device NameSkid, Bone
Regulation DescriptionOrthopedic Manual Surgical Instrument.
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) Exempt
CFR Regulation Number888.4540 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHWO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4496
DeviceSkid, Bone
Product CodeHWO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOrthopedic Manual Surgical Instrument.
CFR Regulation Number888.4540 [🔎]
TPLC Last Update: 2019-04-02 20:50:31

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