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Genesis Ii

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
GENESIS II FDA UDI
Generic Name
Uncoated knee tibia prosthesis, polyethylene FDA UDI
Device Name
GII/GI PS ARTICULAR INSERT SZ 5-6 13MM L FDA UDI
Model / Reference
71930485 FDA UDI
Description
GII/GI PS ARTICULAR INSERT SZ 5-6 13MM L FDA UDI

Identifiers

Catalog Number
71930485 FDA UDI
Primary DI / UDI-DI
00885556051948 FDA UDI
510(k) Number
K951987 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Uncoated knee tibia prosthesis, polyethylene FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Genesis Ii by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K951987 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI f3153db1-b9d5-479b-9f83-2eb427ed6f8e 37 fields · synced Jun 8, 2026