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

Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained (JWJ) (7) Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite (LXT) (3) Plate, Fixation, Bone (HRS) (3)

Premarket Exempt

Yes No

Clear

Universal 2™ Total Wrist System - 10381780066194 Catalog Number : 263800LF

Device Description : The Universal 2 Total Wrist radial component has a concave articulating surface The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by means of a stem which is inserted and cemented into the radial intramedullary canal.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : JWJ

Prescription Use : Yes

Device Count : 1

Universal 2™ Total Wrist System - 10381780066200 Catalog Number : 263800RT

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : JWJ

Prescription Use : Yes

Device Count : 1

Universal 2™ Total Wrist System - 10381780066217 Catalog Number : 264515S

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 - 10381780066224 Catalog Number : 264520S

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 - 10381780066231 Catalog Number : 264525S

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 - 10381780066248 Catalog Number : 264530S

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 - 10381780066255 Catalog Number : 264535S

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

Integra® Total Wrist Fusion System - 10381780066262 Catalog Number : 303100S

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 - 10381780066279 Catalog Number : 303101S

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 : HRS, LXT

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780066286 Catalog Number : 303102S

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : LXT, HRS

Prescription Use : Yes

Device Count : 1

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