Nexgen® Trabecular Metal™

FDA UDI

Class II (US FDA UDI)

by Zimmer Trabecular Metal Technology, Inc.

Identity

Trade Name: NEXGEN® TRABECULAR METAL™ FDA UDI
Generic Name: Metal-backed patella prosthesis FDA UDI
Model / Reference: 00-5878-065-38 FDA UDI

Identifiers

Catalog Number: 00-5878-065-38 FDA UDI
Primary DI / UDI-DI: 00889024309821 FDA UDI
FDA Product Code: MBH FDA UDI
JWH FDA UDI
OIY FDA UDI
GMDN Term: Metal-backed patella prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3565 FDA UDI
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

FDA UDI

Category: Metal-backed patella prosthesis

Nexgen® Trabecular Metal™ by Zimmer Trabecular Metal Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 Trabecular Metal Technology, Inc.

Sources (1)

FDA UDI 673d2ddd-9204-4242-a2f2-298688e166e6 35 fields · synced May 31, 2026