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)

Premarket Exempt

No Yes

Clear

Viper® Distal Volar Radius Plating System - 10381780065012 Catalog Number : 27142724

Device Description : The Viper Variable Angle Locking Technology (VALT) titanium screw, which is plac The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065029 Catalog Number : 27142726

Device Description : The Viper Variable Angle Locking Technology (VALT) titanium screw, which is plac The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065036 Catalog Number : 27142728

Device Description : The Viper Variable Angle Locking Technology (VALT) titanium screw, which is plac The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065043 Catalog Number : 27142730

Device Description : The Viper Variable Angle Locking Technology (VALT) titanium screw, which is plac The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065050 Catalog Number : 27142732

Device Description : The Viper Variable Angle Locking Technology (VALT) titanium screw, which is plac The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065067 Catalog Number : 27142734

Device Description : The Viper Variable Angle Locking Technology (VALT) titanium screw, which is plac The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065074 Catalog Number : 27142736

Device Description : The Viper Variable Angle Locking Technology (VALT) titanium screw, which is plac The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065081 Catalog Number : 27142738

Device Description : The Viper Variable Angle Locking Technology (VALT) titanium screw, which is plac The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780065098 Catalog Number : 28006401

Device Description : The Viper distal volar radius plate consists of four holes with left to right co The Viper distal volar radius plate consists of four 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 - 10381780065104 Catalog Number : 28006402

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

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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