Biomet® Bone Cement R

FDA UDI

Class II (US FDA UDI)

by Biomet, Inc.

Identity

Trade Name: BIOMET® BONE CEMENT R FDA UDI
Generic Name: Orthopaedic cement, non-antimicrobial FDA UDI
Model / Reference: 110035368 FDA UDI

Identifiers

Catalog Number: 110035368 FDA UDI
Primary DI / UDI-DI: 00887868214578 FDA UDI
510(k) Number: K172408 FDA UDI
FDA Product Code: LOD FDA UDI
GMDN Term: Orthopaedic cement, non-antimicrobial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3027 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

MRI Safety

MR Safe FDA UDI

Category: Orthopaedic cement, non-antimicrobial

Biomet® Bone Cement R by Biomet, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K172408 also covers:

BIOMET® BONE CEMENT R — Biomet, Inc.

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: Biomet, Inc.

Sources (1)

FDA UDI e1aea920-9780-4f5f-b9a1-cd80e09c08e0 35 fields · synced May 31, 2026