Femoral Head Trial

FDA UDI

Class I (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name: Femoral Head Trial FDA UDI
Generic Name: Femoral head prosthesis trial FDA UDI
Device Name: 32mm Femoral Head Trial, Green, +3.5mm offset FDA UDI
Model / Reference: 1306.32.350 FDA UDI
Description: 32mm Femoral Head Trial, Green, +3.5mm offset FDA UDI

Identifiers

Primary DI / UDI-DI: 00819251021135 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Femoral head prosthesis trial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Femoral head prosthesis trial

Femoral Head Trial by Total Joint Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femoral head prosthesis trial.

BI-METRIC(R) HEAD/NECK PROVISIONAL — Biomet Orthopedics, Inc. · Class I
Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
CHARNLEY — DEPUY INTERNATIONAL LTD · Class I
AcuMatch — Exactech, Inc. · Class I
G7® — Biomet Orthopedics, Inc. · Class II
AcuMatch — Exactech, Inc. · Class I
NovoHip Total Hip System — Novosource, Inc. · Class II
REVISED BALANCE TRUNNION — Biomet Orthopedics, Inc. · 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: Total Joint Orthopedics, Inc.

Sources (1)

FDA UDI 29530a68-6bef-4293-8fe1-28741255b53a 36 fields · synced Jun 1, 2026