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

Clear

TREGOR® - 03663703000301 Catalog Number : 12600977U

Device Description : Uncemented tripode cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000318 Catalog Number : 12620977U

Device Description : Uncemented tripode cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000325 Catalog Number : 12640977U

Device Description : Uncemented tripode cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000332 Catalog Number : 12520840

Device Description : Cemented cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000349 Catalog Number : 12540840

Device Description : Cemented cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000356 Catalog Number : 12560840

Device Description : Cemented cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000363 Catalog Number : 12580840

Device Description : Cemented cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000370 Catalog Number : 12600840

Device Description : Cemented cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000387 Catalog Number : 12590814U

Device Description : Reinforcement device

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000394 Catalog Number : 12630814U

Device Description : Reinforcement device

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

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