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) (10)

Premarket Exempt

No Yes

Clear

U2 Total Knee System - 04719886890754 Catalog Number : 9304-2330

Device Description : PS Notch cutting jig, #3

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890761 Catalog Number : 9304-2340

Device Description : PS Notch cutting jig, #4

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890778 Catalog Number : 9304-2350

Device Description : PS Notch cutting jig, #5

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890785 Catalog Number : 9304-2360

Device Description : PS Notch cutting jig, #6

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890792 Catalog Number : 9304-2370

Device Description : PS Notch cutting jig, #7

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890815 Catalog Number : 9304-5111

Device Description : Femoral A/P chamfer resection guide extractor

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U-Motion II - 04719886891027 Catalog Number : 9206-1113-RA

Device Description : Straight screw driver

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U-Motion II - 04719886891034 Catalog Number : 9206-1114-RA

Device Description : Universal screw driver

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886891997 Catalog Number : 9304-5104-RA

Device Description : Ortho mallet

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

UCP Stem - 04719886892048 Catalog Number : 9107-6099

Device Description : UCP Starter broach

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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