Ascension Orthopedics, Inc.

Address:11101 Metric Blvd,Austin,TX,78758,US

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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

Plate, Fixation, Bone (HRS) (10) Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite (LXT) (2)

Premarket Exempt

Yes No

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Viper® Distal Volar Radius Plating System - 10381780065111 Catalog Number : 28006601

Device Description : The Viper distal volar radius plate consists of six holes with left to right con The Viper distal volar radius plate consists of six holes with left to right configuration.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065128 Catalog Number : 28006602

Device Description : The Viper distal volar radius plate consists of six holes with left to right con The Viper distal volar radius plate consists of six holes with left to right configuration.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065135 Catalog Number : 2813508

Device Description : The Viper cortical titanium screw, which is placed proximally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065142 Catalog Number : 28135010

Device Description : The Viper cortical titanium screw, which is placed proximally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065159 Catalog Number : 28135012

Device Description : The Viper cortical titanium screw, which is placed proximally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065166 Catalog Number : 28135014

Device Description : The Viper cortical titanium screw, which is placed proximally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065173 Catalog Number : 28135016

Device Description : The Viper cortical titanium screw, which is placed proximally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065180 Catalog Number : 28135018

Device Description : The Viper cortical titanium screw, which is placed proximally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065197 Catalog Number : 303100

Device Description : The Integra Total Wrist Fusion straight plate with nine holes is fixed to the bo The Integra Total Wrist Fusion straight plate with nine holes is fixed to the bone with screws.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : LXT, HRS

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065203 Catalog Number : 303101

Device Description : The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed t The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with screws.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : LXT, HRS

Prescription Use : Yes

Device Count : 1

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