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 - 04719886890143 Catalog Number : 9304-2420

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

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890150 Catalog Number : 9304-2425

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

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890167 Catalog Number : 9304-2430

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

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890174 Catalog Number : 9304-2435

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

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890181 Catalog Number : 9304-2440

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

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890198 Catalog Number : 9304-2445

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

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890204 Catalog Number : 9304-2450

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

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890211 Catalog Number : 9304-2455

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

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890228 Catalog Number : 9304-2460

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

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886890235 Catalog Number : 9304-2465

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

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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