TaperSet Hip System/Consensus Hip System/UniSyn Hip System

FDA UDI

Class I (US FDA UDI)

by Shalby Advanced Technologies, Inc.

Identity

Trade Name: TaperSet Hip System/Consensus Hip System/UniSyn Hip System FDA UDI
Generic Name: Femoral head prosthesis trial FDA UDI
Device Name: Femoral Head Trial, 36mm, +10mm FDA UDI
Model / Reference: 0907-3-3604 FDA UDI
Description: Femoral Head Trial, 36mm, +10mm FDA UDI

Identifiers

Catalog Number: 0907-3-3604 FDA UDI
Primary DI / UDI-DI: 00840286840941 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Femoral head prosthesis trial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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

Yes

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

TaperSet Hip System/Consensus Hip System/UniSyn Hip System by Shalby Advanced Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Femoral head prosthesis trial.

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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
NovoHip Total Hip System — Novosource, 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 I	Pending data

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Manufacturer

Manufacturer: Shalby Advanced Technologies, Inc.

Sources (1)

FDA UDI 24b9d26a-8418-46f4-b740-f6997c3e6f32 36 fields · synced Jun 8, 2026