IMPLANTS INTERNATIONAL LTD

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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) (9)

Premarket Exempt

Clear

SLK Evo - 05051693400757 Catalog Number : KS5736

Device Description : Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 7mm (Thick)

Device Class : 2

Duns Number: 346627222

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SLK Evo - 05051693400764 Catalog Number : KS5737

Device Description : Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 9mm (Thick)

Device Class : 2

Duns Number: 346627222

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SLK Evo - 05051693400771 Catalog Number : KS5738

Device Description : Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 1 Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 11mm (Thick)

Device Class : 2

Duns Number: 346627222

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SLK Evo - 05051693400788 Catalog Number : KS5739

Device Description : Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 1 Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 13mm (Thick)

Device Class : 2

Duns Number: 346627222

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SLK Evo - 05051693400795 Catalog Number : KS5740

Device Description : Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 1 Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 70mm (Width), 15mm (Thick)

Device Class : 2

Duns Number: 346627222

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SLK Evo - 05051693400801 Catalog Number : KS5741

Device Description : Patella Button (UHMWPE), Denoted size 32mm (Dia)

Device Class : 2

Duns Number: 346627222

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SLK Evo - 05051693400818 Catalog Number : KS5742

Device Description : Patella Button (UHMWPE), Denoted size 34mm (Dia)

Device Class : 2

Duns Number: 346627222

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SLK Evo - 05051693400825 Catalog Number : KS5743

Device Description : Patella Button (UHMWPE), Denoted size 36mm (Dia)

Device Class : 2

Duns Number: 346627222

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SLK Evo - 05051693400832 Catalog Number : KS5744

Device Description : Patella Button (UHMWPE), Denoted size 38mm (Dia)

Device Class : 2

Duns Number: 346627222

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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