SLK Evo

FDA UDI

Class II (US FDA UDI)

by Implants International Ltd

Identity

Trade Name: SLK Evo FDA UDI
Generic Name: Posterior-stabilized total knee prosthesis FDA UDI
Device Name: Cruciate Sacrificing (Posterior Stabilised) Femoral Componant for Cemented applications (Cobalt Chrome), Denoted size 65mm (Width) Anatomical Orientation - Left FDA UDI
Model / Reference: CS Femoral (PS) Left 65mm FDA UDI
Description: Cruciate Sacrificing (Posterior Stabilised) Femoral Componant for Cemented applications (Cobalt Chrome), Denoted size 65mm (Width) Anatomical Orientation - Left FDA UDI

Identifiers

Catalog Number: KS5988 FDA UDI
Primary DI / UDI-DI: 05051693400290 FDA UDI
510(k) Number: K980999 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Posterior-stabilized total knee prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Width — 65 Millimeter FDA UDI

Category: Posterior-stabilized total knee prosthesis

SLK Evo by Implants International Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Posterior-stabilized total knee prosthesis.

Evolution — MicroPort Orthopedics Inc. · Class II
Evolution — MicroPort Orthopedics Inc. · Class II
NovoKnee Total Knee System — Novosource, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Evolution — MicroPort Orthopedics Inc. · Class II
Evolution — MicroPort Orthopedics Inc. · Class II
Consensus MBK System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Implants International Ltd

Sources (1)

FDA UDI 57d75591-711b-4d51-92f8-de2a99d18b92 38 fields · synced May 31, 2026