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

Trousers, anti-shock (LHX) (10)

Premarket Exempt

No Yes

Clear

CADENCE® - 10381780527237 Catalog Number : 10200112

Device Description : Cadence®Total Ankle System, Flat Cut Talar Trial, Size 2, Right

Device Class : 2

Duns Number: 942377524

Premarket Exempt : Yes

Product Code : LHX

Prescription Use : Yes

Device Count : 1

CADENCE® - 10381780527244 Catalog Number : 10200113

Device Description : Cadence®Total Ankle System, Flat Cut Talar Trial, Size 3, Right

Device Class : 2

Duns Number: 942377524

Premarket Exempt : Yes

Product Code : LHX

Prescription Use : Yes

Device Count : 1

CADENCE® - 10381780527251 Catalog Number : 10200114

Device Description : Cadence®Total Ankle System, Flat Cut Talar Trial, Size 4, Right

Device Class : 2

Duns Number: 942377524

Premarket Exempt : Yes

Product Code : LHX

Prescription Use : Yes

Device Count : 1

CADENCE® - 10381780527268 Catalog Number : 10200115

Device Description : Cadence®Total Ankle System, Flat Cut Talar Trial, Size 5, Right

Device Class : 2

Duns Number: 942377524

Premarket Exempt : Yes

Product Code : LHX

Prescription Use : Yes

Device Count : 1

CADENCE® - 10381780527282 Catalog Number : 10200211

Device Description : Cadence®Total Ankle System, Flat Cut Talar Trial, Size 1, Left

Device Class : 2

Duns Number: 942377524

Premarket Exempt : Yes

Product Code : LHX

Prescription Use : Yes

Device Count : 1

CADENCE® - 10381780527299 Catalog Number : 10200212

Device Description : Cadence®Total Ankle System, Flat Cut Talar Trial, Size 2, Left

Device Class : 2

Duns Number: 942377524

Premarket Exempt : Yes

Product Code : LHX

Prescription Use : Yes

Device Count : 1

CADENCE® - 10381780527305 Catalog Number : 10200213

Device Description : Cadence®Total Ankle System, Flat Cut Talar Trial, Size 3, Left

Device Class : 2

Duns Number: 942377524

Premarket Exempt : Yes

Product Code : LHX

Prescription Use : Yes

Device Count : 1

CADENCE® - 10381780527312 Catalog Number : 10200214

Device Description : Cadence®Total Ankle System, Flat Cut Talar Trial, Size 4, Left

Device Class : 2

Duns Number: 942377524

Premarket Exempt : Yes

Product Code : LHX

Prescription Use : Yes

Device Count : 1

CADENCE® - 10381780527329 Catalog Number : 10200215

Device Description : Cadence®Total Ankle System, Flat Cut Talar Trial, Size 5, Left

Device Class : 2

Duns Number: 942377524

Premarket Exempt : Yes

Product Code : LHX

Prescription Use : Yes

Device Count : 1

CADENCE® - 10381780527336 Catalog Number : 10200101

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

Device Class : 2

Duns Number: 942377524

Premarket Exempt : Yes

Product Code : LHX

Prescription Use : Yes

Device Count : 1

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