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, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented (KWY) (8) Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (LPH) (1) Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented (LWJ) (1) Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate (MEH) (1)

Premarket Exempt

No Yes

Clear

U2 Acetabular Cup Liner - 04711605560986 Catalog Number : 1403-5044

Device Description : U2 Acetabular cup liner,ID 26mm 10°hooded,44mm (for CCM Cup)

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

United Hip System, Center Hole Screw & Plug, Cemented - 04711605560993 Catalog Number : 1301-1010-C

Device Description : Acetabular cup Center Hole Screw & plastic plug set, cemented

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : LWJ, MEH

Prescription Use : Yes

Device Count : 1

U1 Hip System, Bipolar Cup - 04711605564823 Catalog Number : 1501-1057

Device Description : U1 Bipolar cap,57mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

U1 Hip System, Bipolar Cup - 04711605564830 Catalog Number : 1501-1058

Device Description : U1 Bipolar cap,58mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

U1 Hip System, Bipolar Cup - 04711605564847 Catalog Number : 1501-1059

Device Description : U1 Bipolar cap,59mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

U1 Hip System, Bipolar Cup - 04711605564854 Catalog Number : 1501-1060

Device Description : U1 Bipolar cap,60mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

U1 Hip System, Bipolar Cup - 04711605564861 Catalog Number : 1501-1061

Device Description : U1 Bipolar cap,61mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

U1 Hip System, Bipolar Cup - 04711605564878 Catalog Number : 1501-1062

Device Description : U1 Bipolar cap,62mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

U1 Hip System, Bipolar Cup Liner - 04711605564885 Catalog Number : 1601-1057

Device Description : U1 Bipolar cap liner,57mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

U1 Hip System, Bipolar Cup Liner - 04711605564892 Catalog Number : 1601-1058

Device Description : U1 Bipolar cap liner,58mm

Device Class : 2

Duns Number: 656700556

Premarket Exempt : No

Product Code : KWY

Prescription Use : Yes

Device Count : 1

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