MiniMAX Stems

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name: MiniMAX Stems FDA UDI
Generic Name: Press-fit hip femur prosthesis, one-piece FDA UDI
Device Name: Cementless Anatomical Stem, Left, Size 9 FDA UDI
Model / Reference: 01.13.109L FDA UDI
Description: Cementless Anatomical Stem, Left, Size 9 FDA UDI

Identifiers

Primary DI / UDI-DI: 07630971238794 FDA UDI
FDA Product Code: LZO FDA UDI
MEH FDA UDI
KWY FDA UDI
LZY FDA UDI
GMDN Term: Press-fit hip femur prosthesis, one-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3390 FDA UDI
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

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: Press-fit hip femur prosthesis, one-piece

MiniMAX Stems by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Press-fit hip femur prosthesis, one-piece.

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RECLAIMTM — DEPUY (IRELAND) · Class II
Novosource Total Hip System — Novosource, Inc. · Class II
PROFEMUR® — MicroPort Orthopedics Inc. · Class II
NEXUS — MicroPort Orthopedics Inc. · Class II
Trivicta — ORTHO DEVELOPMENT CORP. · 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: Medacta International

Sources (1)

FDA UDI 0e38de0d-cf0e-4280-b178-734e82065c36 33 fields · synced Jun 6, 2026