Consensus Hip System

FDA UDI

Class II (US FDA UDI)

by Shalby Advanced Technologies, Inc.

Identity

Trade Name: Consensus Hip System FDA UDI
Generic Name: Metallic femoral head prosthesis FDA UDI
Device Name: Unipolar Head, 49mm, ±0mm FDA UDI
Model / Reference: 1017-0-1049 FDA UDI
Description: Unipolar Head, 49mm, ±0mm FDA UDI

Identifiers

Catalog Number: 1017-0-1049 FDA UDI
Primary DI / UDI-DI: 00840286802970 FDA UDI
FDA Product Code: KWL FDA UDI
GMDN Term: Metallic femoral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3360 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

Yes

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: Metallic femoral head prosthesis

Consensus Hip System by Shalby Advanced Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Metallic femoral head prosthesis.

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A110212031 — EUROS SAS · Class III
BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
ic-head CoCrMo taper 12/14 — implantcast GmbH · Class II
RINGLOC MALLORY HEAD HIP SYSTEM — Biomet Orthopedics, Inc. · Class II

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: Shalby Advanced Technologies, Inc.

Sources (1)

FDA UDI a9f2e92c-7139-4cbb-b835-45f4b457c687 35 fields · synced May 30, 2026