UNITED ORTHOPEDIC CORP.

Address:57 PARK AVE. 2, SCIENCE PARK,HSINCHU Hsinchu (City),TW

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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

Orthopedic Manual Surgical Instrument (LXH) (7) Bit, Drill (HTW) (3)

Premarket Exempt

No Yes

Clear

U2 Total Knee System - 04719886892055 Catalog Number : 9403-3411

Device Description : Tibial drill, NON-CEM, Ø11.5mm

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886892062 Catalog Number : 9403-3412

Device Description : Tibial drill, NON-CEM, Ø12.5mm

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886892079 Catalog Number : 9403-3412-RA

Device Description : Tibial drill, NON-CEM, Ø12.5mm

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886892086 Catalog Number : 9404-1301

Device Description : Tibial punch adaptor, NON-CEM

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886892093 Catalog Number : 9404-2611

Device Description : Tibial drill guide, NON-CEM, Ø11.5mm

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886892109 Catalog Number : 9404-2612

Device Description : Tibial drill guide, NON-CEM, Ø12.5mm

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886892116 Catalog Number : 9404-2901

Device Description : Tibial tower, NON-CEM, #1~#2

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886892123 Catalog Number : 9404-2902

Device Description : Tibial tower, NON-CEM, #3~#5

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886892130 Catalog Number : 9404-2903

Device Description : Tibial tower, NON-CEM, #6~#7

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886892147 Catalog Number : 9404-5104

Device Description : Stem assembly handle

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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