Gmrs

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: GMRS FDA UDI
Generic Name: Coated femoral stem prosthesis, modular FDA UDI
Device Name: Proximal Femoral Component FDA UDI
Model / Reference: 6495-1-001 FDA UDI
Description: Proximal Femoral Component FDA UDI

Identifiers

Catalog Number: 6495-1-001 FDA UDI
Primary DI / UDI-DI: 07613327048704 FDA UDI
510(k) Number: K023087 FDA UDI
FDA Product Code: JDI FDA UDI
KRO FDA UDI
GMDN Term: Coated femoral stem prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 FDA UDI
888.3510 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 femoral stem prosthesis, modular

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

Similar devices

Also classified as Coated femoral stem prosthesis, modular.

MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
PROFEMUR® — MicroPort Orthopedics Inc. · Class II
MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Alteon — Exactech, Inc. · Class II
ANTHOLOGY — Smith & Nephew, Inc. · Class III
TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II

Cleared under the same submission

K023087 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: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 9843ee93-d71d-4c93-8cb9-550bb49cb6e5 36 fields · synced May 30, 2026