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

Bit, Drill (HTW) (2) Driver, Prosthesis (HWR) (2) Extractor (HWB) (1)

Premarket Exempt

No Yes

Clear

U2 Total Knee System - 04719886892925 Catalog Number : 9404-3003

Device Description : Tibial peg drill, NON-CEM

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886892932 Catalog Number : 9403-3407

Device Description : Tibial peg dilator, NON-CEM

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

U2 Total Knee System - 04719886893069 Catalog Number : 9403-5101-RH

Device Description : Tibial baseplate driver

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : HWR

Prescription Use : Yes

Device Count : 1

Resolve Modular Stem - 04719886893076 Catalog Number : 9112-5201

Device Description : Stem trial extractor

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : HWB

Prescription Use : Yes

Device Count : 1

DM Acetabular System - 04719886893229 Catalog Number : 9207-1303-RA

Device Description : Cup positioner, offset

Device Class : 1

Duns Number: 656700556

Premarket Exempt : Yes

Product Code : HWR

Prescription Use : Yes

Device Count : 1

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