Fitmore®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: Fitmore® FDA UDI
Generic Name: Coated hip femur prosthesis, modular FDA UDI
Model / Reference: 01.00551.407 FDA UDI

Identifiers

Catalog Number: 01.00551.407 FDA UDI
Primary DI / UDI-DI: 00889024591899 FDA UDI
FDA Product Code: JDI FDA UDI
KWL FDA UDI
KWY FDA UDI
KWZ FDA UDI
LWJ FDA UDI
LZO FDA UDI
GMDN Term: Coated hip femur prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 FDA UDI
888.3360 FDA UDI
888.3390 FDA UDI
888.3310 FDA UDI
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

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

MRI Safety

MR Conditional FDA UDI

Category: Coated hip femur prosthesis, modular

Fitmore® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Coated hip femur prosthesis, modular.

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CATALYSTEM — Smith & Nephew, Inc. · Class II
Everglade Stem, Standard Offset — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Excia® L — AESCULAP, INC. · Class II
SYNERGY — Smith & Nephew, Inc. · Class II
SYNERGY — Smith & Nephew, 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 II	Pending data

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Manufacturer

Manufacturer: Zimmer, Inc.

Sources (1)

FDA UDI 784abbfe-15bd-4b64-87b8-ecec07a92918 35 fields · synced May 31, 2026