Ascension Orthopedics, Inc.

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

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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

Plate, Fixation, Bone (HRS) (8) Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained (JWJ) (2)

Premarket Exempt

No Yes

Clear

Universal 2™ Total Wrist System - 10381780064909 Catalog Number : 264530

Device Description : The Universal 2 Total Wrist cancellous bone screw implant.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : JWJ

Prescription Use : Yes

Device Count : 1

Universal 2™ Total Wrist System - 10381780064916 Catalog Number : 264535

Device Description : The Universal 2 Total Wrist cancellous bone screw implant.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : JWJ

Prescription Use : Yes

Device Count : 1

Viper® Distal Volar Radius Plating System - 10381780064923 Catalog Number : 27142710

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 - 10381780064930 Catalog Number : 27142712

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 - 10381780064947 Catalog Number : 27142714

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 - 10381780064954 Catalog Number : 27142716

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 - 10381780064961 Catalog Number : 27142718

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 - 10381780064978 Catalog Number : 27142720

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 - 10381780064985 Catalog Number : 27142722

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 - 10381780065005 Catalog Number : 27142708

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

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