Mallory/Head Modular

FDA UDI

Class I (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: MALLORY/HEAD MODULAR FDA UDI
Generic Name: Femoral stem prosthesis trial FDA UDI
Model / Reference: 31-108115 FDA UDI

Identifiers

Catalog Number: 31-108115 FDA UDI
Primary DI / UDI-DI: 00880304302570 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Femoral stem prosthesis trial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Femoral stem prosthesis trial

Mallory/Head Modular by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femoral stem prosthesis trial.

S-ROM — DEPUY ORTHOPAEDICS, INC. · Class I
S-ROM — DEPUY ORTHOPAEDICS, INC. · Class I
S-ROM — DEPUY ORTHOPAEDICS, INC. · Class I
EXACT REVERSE FP FULL TOOTH RASP — Zimmer, Inc. · Class I
INSTRUMENT — Howmedica Osteonics Corp. · Class I
ZMR® — Zimmer, Inc. · Class II
PROFEMUR — MicroPort Orthopedics Inc. · Class I
INSTRUMENT — Howmedica Osteonics Corp. · Class I

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI e07b6b6d-8ac0-4510-8357-e929a955c880 34 fields · synced May 30, 2026