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

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES (HSB) (8) Trousers, anti-shock (LHX) (2)

Premarket Exempt

No Yes

Clear

CADENCE® - 10381780527343 Catalog Number : 10200102

Device Description : Cadence®Total Ankle System, 2mm Talar Cut Guide

Device Class : 2

Duns Number: 942377524

Premarket Exempt : Yes

Product Code : LHX

Prescription Use : Yes

Device Count : 1

CADENCE® - 10381780527350 Catalog Number : 10200104

Device Description : Cadence®Total Ankle System, Talar Flat Cut Guide

Device Class : 2

Duns Number: 942377524

Premarket Exempt : Yes

Product Code : LHX

Prescription Use : Yes

Device Count : 1

Panta® 2 Arthrodesis Nail System - 10381780529088 Catalog Number : PAN-1010-2645NS

Device Description : Partially Threaded C-Screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Panta® 2 Arthrodesis Nail System - 10381780529095 Catalog Number : PAN-1010-2650NS

Device Description : Partially Threaded C-Screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Panta® 2 Arthrodesis Nail System - 10381780529101 Catalog Number : PAN-1010-2655NS

Device Description : Partially Threaded C-Screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Panta® 2 Arthrodesis Nail System - 10381780529118 Catalog Number : PAN-1010-2665NS

Device Description : Partially Threaded C-Screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Panta® 2 Arthrodesis Nail System - 10381780529125 Catalog Number : PAN-1010-2670NS

Device Description : Partially Threaded C-Screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Panta® 2 Arthrodesis Nail System - 10381780529132 Catalog Number : PAN-1010-2675NS

Device Description : Partially Threaded C-Screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Panta® 2 Arthrodesis Nail System - 10381780529149 Catalog Number : PAN-1010-2680NS

Device Description : Partially Threaded C-Screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Panta® 2 Arthrodesis Nail System - 10381780529156 Catalog Number : PAN-1010-2685NS

Device Description : Partially Threaded C-Screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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