Anvil, Skull Plate

Device Code: 3662

Product Code(s): GXM

Device Classification Information

Device Type ID3662
Device NameAnvil, Skull Plate
Regulation DescriptionSkull Plate Anvil.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
Submission Type510(K) Exempt
CFR Regulation Number882.4030 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGXM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3662
DeviceAnvil, Skull Plate
Product CodeGXM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSkull Plate Anvil.
CFR Regulation Number882.4030 [🔎]
TPLC Last Update: 2019-04-02 20:34:01

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