Zmr®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: ZMR® FDA UDI
Generic Name: Revision coated hip femur prosthesis FDA UDI
Model / Reference: 9998-19-35 FDA UDI

Identifiers

Catalog Number: 00-9998-019-35 FDA UDI
Primary DI / UDI-DI: 00889024162631 FDA UDI
510(k) Number: K113296 FDA UDI
K994286 FDA UDI
FDA Product Code: KWZ FDA UDI
LWJ FDA UDI
LPH FDA UDI
JDI FDA UDI
LZO FDA UDI
GMDN Term: Revision coated hip femur prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3310 FDA UDI
888.3360 FDA UDI
888.3358 FDA UDI
888.3350 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

Category: Revision coated hip femur prosthesis

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

Similar devices

Also classified as Revision coated hip femur prosthesis.

M-Vizion Femoral Revision System — Medacta International · Class II
M-Vizion Femoral Revision System — Medacta International · Class II
M-Vizion Femoral Revision System — Medacta International · Class II
M-Vizion Femoral Revision System — Medacta International · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
UniSyn Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
UniSyn Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
M-Vizion Femoral Revision System — Medacta International · Class II

Cleared under the same submission

K113296 also covers:

K994286 also covers:

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 ad61f72c-051d-4be2-98e4-71084e66b375 36 fields · synced May 30, 2026