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

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

Premarket Exempt

Yes No

Clear

Integra® Total Wrist Fusion System - 10381780065210 Catalog Number : 303102

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 - 10381780065227 Catalog Number : 303210

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : LXT, HRS

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065234 Catalog Number : 303212

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS, LXT

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065241 Catalog Number : 303214

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : LXT, HRS

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065258 Catalog Number : 303216

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS, LXT

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065265 Catalog Number : 303218

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : LXT, HRS

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065272 Catalog Number : 303220

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS, LXT

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065289 Catalog Number : 303222

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : LXT, HRS

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065296 Catalog Number : 303224

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS, LXT

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065302 Catalog Number : 303312

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : LXT, HRS

Prescription Use : Yes

Device Count : 1

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