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) (6) Extractor (HWB) (1) Impactor (HWA) (1) Punch, Femoral Neck (HWP) (1) Reamer (HTO) (1)

Premarket Exempt

No Yes

Clear

U2 Total Knee System - 04719886890341 Catalog Number : 9304-2655

Device Description : Femoral A/P chamfer resection guide, PR, #5.5

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890358 Catalog Number : 9304-2660

Device Description : Femoral A/P chamfer resection guide, PR, #6

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890365 Catalog Number : 9304-2665

Device Description : Femoral A/P chamfer resection guide, PR, #6.5

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890372 Catalog Number : 9304-2670

Device Description : Femoral A/P chamfer resection guide, PR, #7

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890389 Catalog Number : 9304-5108-RC

Device Description : Femoral chamfer resection guide extractor

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : HWB

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890433 Catalog Number : 9304-4101-RE

Device Description : PS Reamer

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890440 Catalog Number : 9304-4102-RE

Device Description : PS Housing punch

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : HWP

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890457 Catalog Number : 9304-4103-RE

Device Description : PS Housing impactor

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890730 Catalog Number : 9304-2310

Device Description : PS Notch cutting jig, #1

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890747 Catalog Number : 9304-2320

Device Description : PS Notch cutting jig, #2

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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