ASTON MEDICAL

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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (LZO) (7) Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate (MEH) (3)

Premarket Exempt

No

Clear

TREGOR® - 03663703000004 Catalog Number : 12522870

Device Description : Mobile insert

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000011 Catalog Number : 12542870

Device Description : Mobile insert

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000028 Catalog Number : 12562870

Device Description : Mobile insert

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000035 Catalog Number : 12582870

Device Description : Mobile insert

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000042 Catalog Number : 12602870

Device Description : Mobile insert

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000059 Catalog Number : 12622870

Device Description : Mobile insert

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000066 Catalog Number : 12642870

Device Description : Mobile insert

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000073 Catalog Number : 12521970U

Device Description : Uncemented standard cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000080 Catalog Number : 12541970U

Device Description : Uncemented standard cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000097 Catalog Number : 12561970U

Device Description : Uncemented standard cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

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