NovoHip Total Hip System

FDA UDI

Class II (US FDA UDI)

by Novosource, Inc.

Identity

Trade Name: NovoHip Total Hip System FDA UDI
Generic Name: Femoral head prosthesis trial FDA UDI
Device Name: Femoral Head, Trial Sz 36 XL FDA UDI
Model / Reference: 1400-3604 FDA UDI
Description: Femoral Head, Trial Sz 36 XL FDA UDI

Identifiers

Catalog Number: 1400-3604 FDA UDI
Primary DI / UDI-DI: 00811382033629 FDA UDI
510(k) Number: K132158 FDA UDI
FDA Product Code: LPH FDA UDI
LZO FDA UDI
GMDN Term: Femoral head prosthesis trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
888.3353 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

Dimensions & Sizes

Size: Outer Diameter — 36 Millimeter FDA UDI

Category: Femoral head prosthesis trial

NovoHip Total Hip System by Novosource, Inc. — Class II — 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
Klassic Femoral Head Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
AcuMatch — Exactech, Inc. · Class I
G7® — Biomet Orthopedics, Inc. · Class II
AcuMatch — Exactech, Inc. · Class I
REVISED BALANCE TRUNNION — Biomet Orthopedics, Inc. · Class I

Cleared under the same submission

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: Novosource, Inc.

Sources (1)

FDA UDI 1587c48c-bee4-4cf9-a0ff-1916933234c1 37 fields · synced Jun 8, 2026