Abg

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: ABG FDA UDI
Generic Name: Coated hip femur prosthesis, modular FDA UDI
Device Name: Femoral Stem - Left FDA UDI
Model / Reference: 4845-0201 FDA UDI
Description: Femoral Stem - Left FDA UDI

Identifiers

Catalog Number: 4845-0201 FDA UDI
Primary DI / UDI-DI: 07613327050998 FDA UDI
FDA Product Code: KWY FDA UDI
LPH FDA UDI
MAY FDA UDI
JDI FDA UDI
KWZ FDA UDI
MEH FDA UDI
MBL FDA UDI
LZO FDA UDI
LWJ FDA UDI
KWL FDA UDI
GMDN Term: Coated hip femur prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3390 FDA UDI
888.3358 FDA UDI
888.3353 FDA UDI
888.3350 FDA UDI
888.3310 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

FDA UDI

Manufacturing Date

FDA UDI

Category: Coated hip femur prosthesis, modular

Abg by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated hip femur prosthesis, modular.

LCU Hip Stem — WALDEMAR LINK GmbH & Co. KG · Class II
Z1™ Hip System — Zimmer, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
VerSys® — Zimmer, Inc. · Class II
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

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: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 4bef3fed-2b7e-444e-8bbe-a567bba8e810 35 fields · synced May 30, 2026