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 - 04719886890242 Catalog Number : 9304-2470

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

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890259 Catalog Number : 9304-2610

Device Description : Femoral A/P chamfer resection guide, PR, #1

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890266 Catalog Number : 9304-2615

Device Description : Femoral A/P chamfer resection guide, PR, #1.5

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890273 Catalog Number : 9304-2620

Device Description : Femoral A/P chamfer resection guide, PR, #2

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890280 Catalog Number : 9304-2625

Device Description : Femoral A/P chamfer resection guide, PR, #2.5

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890297 Catalog Number : 9304-2630

Device Description : Femoral A/P chamfer resection guide, PR, #3

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890303 Catalog Number : 9304-2635

Device Description : Femoral A/P chamfer resection guide, PR, #3.5

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890310 Catalog Number : 9304-2640

Device Description : Femoral A/P chamfer resection guide, PR, #4

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890327 Catalog Number : 9304-2645

Device Description : Femoral A/P chamfer resection guide, PR, #4.5

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890334 Catalog Number : 9304-2650

Device Description : Femoral A/P chamfer resection guide, PR, #5

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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