ASTON MEDICAL

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (10)

Premarket Exempt

Clear

Duocentric® - 03663703000905 Catalog Number : 30436940

Device Description : Retentive humeral insert

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Duocentric® - 03663703000912 Catalog Number : 30440940

Device Description : Retentive humeral insert

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Duocentric® - 03663703000929 Catalog Number : 30194924

Device Description : Glenoid baseplate

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Duocentric® - 03663703000936 Catalog Number : 30294924

Device Description : Glenoid baseplate

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Duocentric® - 03663703000943 Catalog Number : 30192924

Device Description : Glenoid baseplate

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Duocentric® - 03663703000950 Catalog Number : 30292924

Device Description : Glenoid baseplate

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Duocentric® - 03663703000967 Catalog Number : 30236020

Device Description : Duoglene

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Duocentric® - 03663703000974 Catalog Number : 30240020

Device Description : Duoglene

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Duocentric® - 03663703000981 Catalog Number : 83502041

Device Description : Screw

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Duocentric® - 03663703000998 Catalog Number : 83502541

Device Description : Screw

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

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