Smartset

FDA UDI

Class I (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: SMARTSET FDA UDI
Generic Name: Orthopaedic cement, antimicrobial FDA UDI
Device Name: Smartset GHV GENTAMICIN High Viscosity Bone Cement 40g FDA UDI
Model / Reference: 5450-35-500 FDA UDI
Description: Smartset GHV GENTAMICIN High Viscosity Bone Cement 40g FDA UDI

Identifiers

Catalog Number: 545035500 FDA UDI
Primary DI / UDI-DI: 10603295174288 FDA UDI
510(k) Number: K023012 FDA UDI
K033382 FDA UDI
K033563 FDA UDI
K053002 FDA UDI
K053445 FDA UDI
K061144 FDA UDI
K081163 FDA UDI
FDA Product Code: JDZ FDA UDI
LOD FDA UDI
MBB FDA UDI
KIH FDA UDI
GMDN Term: Orthopaedic cement, antimicrobial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4210 FDA UDI
888.3027 FDA UDI
888.4200 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: Orthopaedic cement, antimicrobial

Smartset by Depuy (ireland) — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic cement, antimicrobial.

BonOs HV Genta — OSARTIS GmbH · Class II
PALACOS® — Heraeus Medical LLC · Class II
Refobacin® Bone Cement R — Biomet, Inc. · Class II
Unite Cement — OSTEOREMEDIES, LLC · Class II
MectaCem-X LV with Gentamicin — Tecres · Class II
BRAVO MV+G — G21 SRL · Class II
Simplex — Howmedica Osteonics Corp. · Class II
Cemex Genta HV — Tecres · Class II

Cleared under the same submission

K023012 also covers:

SMARTSET — DEPUY (IRELAND)
SMARTSET — DEPUY (IRELAND)

K033382 also covers:

SMARTSET — DEPUY (IRELAND)

K033563 also covers:

SMARTSET — DEPUY (IRELAND)
SMARTSET — DEPUY (IRELAND)

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: Depuy (ireland)

Sources (1)

FDA UDI c9b59e8b-26c7-41df-9abb-d71c49276736 37 fields · synced Jun 1, 2026