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: Uncoated femoral stem prosthesis, one-piece FDA UDI
Device Name: Femoral Stem, Collared, Tapered, Cemented, 14 FDA UDI
Model / Reference: 1012-3-0014 FDA UDI
Description: Femoral Stem, Collared, Tapered, Cemented, 14 FDA UDI

Identifiers

Catalog Number: 1012-3-0014 FDA UDI
Primary DI / UDI-DI: 00840286802529 FDA UDI
FDA Product Code: LZO FDA UDI
GMDN Term: Uncoated femoral stem prosthesis, one-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 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: Uncoated femoral stem prosthesis, one-piece

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

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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 19267800-01c4-4203-a4d0-b058c0077bff 35 fields · synced May 31, 2026