Consensus Hip System

FDA UDI

Class III (US FDA UDI)

by Shalby Advanced Technologies, Inc.

Identity

Trade Name: Consensus Hip System FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Device Name: Proximal Spacer, 13 FDA UDI
Model / Reference: 1009-0-0013 FDA UDI
Description: Proximal Spacer, 13 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840286802031 FDA UDI
FDA Product Code: JDL FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner FDA UDI

Classification

Device Class: Class III FDA UDI
Regulation Number: 888.3320 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: Non-constrained polyethylene acetabular liner

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

Similar devices

Also classified as Non-constrained polyethylene acetabular liner.

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RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
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PRIME — MicroPort Orthopedics Inc. · Class II
G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
PINNACLE — DEPUY ORTHOPAEDICS, 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 III	Pending data

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Manufacturer

Manufacturer: Shalby Advanced Technologies, Inc.

Sources (1)

FDA UDI 56bc1607-78ee-42f6-b221-89999d2ee995 34 fields · synced May 31, 2026