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

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (6) Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented (KWY) (4)

Premarket Exempt

No Yes

Clear

U1 Hip System, Bipolar Cup Liner - 04711605564908 Catalog Number : 1601-1059

Device Description : U1 Bipolar cap liner,59mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

U1 Hip System, Bipolar Cup Liner - 04711605564915 Catalog Number : 1601-1060

Device Description : U1 Bipolar cap liner,60mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

U1 Hip System, Bipolar Cup Liner - 04711605564922 Catalog Number : 1601-1061

Device Description : U1 Bipolar cap liner,61mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

U1 Hip System, Bipolar Cup Liner - 04711605564939 Catalog Number : 1601-1062

Device Description : U1 Bipolar cap liner,62mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

XPE Tibial insert, UC - 04711605566902 Catalog Number : 2303-1411

Device Description : XPE Tibial insert, UC, #1, 9mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

XPE Tibial insert, UC - 04711605566919 Catalog Number : 2303-1412

Device Description : XPE Tibial insert, UC, #1, 11mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

XPE Tibial insert, UC - 04711605566926 Catalog Number : 2303-1413

Device Description : XPE Tibial insert, UC, #1, 13mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

XPE Tibial insert, UC - 04711605566933 Catalog Number : 2303-1414

Device Description : XPE Tibial insert, UC, #1, 15mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

XPE Tibial insert, UC - 04711605566940 Catalog Number : 2303-1415

Device Description : XPE Tibial insert, UC, #1, 18mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

XPE Tibial insert, UC - 04711605566957 Catalog Number : 2303-1421

Device Description : XPE Tibial insert, UC, #2, 9mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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