Identity
- Trade Name
- SLK Evo FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 65mm (Width), 7mm (Thick) FDA UDI
- Model / Reference
- CR Modular (STD) Tibial insert 65mm x 7mm FDA UDI
- Description
- Cruciate Retaining Standard Tibial Insert (UHMWPE), Denoted size 65mm (Width), 7mm (Thick) FDA UDI
Identifiers
- Catalog Number
- KS5731 FDA UDI
- Primary DI / UDI-DI
- 05051693400702 FDA UDI
- 510(k) Number
- K980999 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Tibial insert 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Width — 65 Millimeter FDA UDI
Category: Tibial insert
SLK Evo by Implants International Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tibial insert.
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Cleared under the same submission
K980999 also covers:
- SLK Evo — IMPLANTS INTERNATIONAL LTD
- SLK Evo — IMPLANTS INTERNATIONAL LTD
- SLK Evo — IMPLANTS INTERNATIONAL LTD
- SLK Evo — IMPLANTS INTERNATIONAL LTD
- SLK Evo — IMPLANTS INTERNATIONAL LTD
- SLK Evo — IMPLANTS INTERNATIONAL LTD
- SLK Evo — IMPLANTS INTERNATIONAL LTD
- SLK Evo — IMPLANTS INTERNATIONAL LTD
- SLK Evo — IMPLANTS INTERNATIONAL LTD
- SLK Evo — IMPLANTS INTERNATIONAL LTD
- SLK Evo — IMPLANTS INTERNATIONAL LTD
- SLK Evo — IMPLANTS INTERNATIONAL LTD
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 ea31a68b-9691-4ba0-8152-676843bcee4d 38 fields · synced May 31, 2026