NexGen

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: NexGen FDA UDI
Generic Name: Knee tibia prosthesis trial, reusable FDA UDI
Model / Reference: SSI004654 FDA UDI

Identifiers

Catalog Number: SSI004654 FDA UDI
Primary DI / UDI-DI: 00889024518377 FDA UDI
510(k) Number: K152494 FDA UDI
FDA Product Code: JWH FDA UDI
KRO FDA UDI
GMDN Term: Knee tibia prosthesis trial, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3510 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Height — 10 Millimeter FDA UDI

Category: Knee tibia prosthesis trial, reusable

NexGen by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Knee tibia prosthesis trial, reusable.

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SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
INSTRUMENT — Howmedica Osteonics Corp. · Class I

Cleared under the same submission

K152494 also covers:

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: Zimmer, Inc.

Sources (1)

FDA UDI a49ce1bd-6dc4-4985-bb15-12c3ce5feb30 36 fields · synced Jun 1, 2026