Ceramics, Calcium Triphosphate/hydroxypatite, Non-load Bearing Uses

Device Code: 4708

Product Code(s): LMN

Device Classification Information

Device Type ID4708
Device NameCeramics, Calcium Triphosphate/hydroxypatite, Non-load Bearing Uses
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Restorative And Repair Devices Branch (RRDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeLMN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4708
DeviceCeramics, Calcium Triphosphate/hydroxypatite, Non-load Bearing Uses
Product CodeLMN
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:54:15

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