Gmrs

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: GMRS FDA UDI
Generic Name: Press-fit femoral stem prosthesis FDA UDI
Device Name: Straight Fluted Press-Fit Stem FDA UDI
Model / Reference: 6495-5-019 FDA UDI
Description: Straight Fluted Press-Fit Stem FDA UDI

Identifiers

Catalog Number: 6495-5-019 FDA UDI
Primary DI / UDI-DI: 07613327033571 FDA UDI
510(k) Number: K022403 FDA UDI
K023087 FDA UDI
K222056 FDA UDI
FDA Product Code: LZO FDA UDI
KRO FDA UDI
JDI FDA UDI
GMDN Term: Press-fit femoral stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3510 FDA UDI
888.3350 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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 125.0 Millimeter FDA UDI

Category: Press-fit femoral stem prosthesis

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

Similar devices

Also classified as Press-fit femoral stem prosthesis.

Echo® Bi-Metric® Hip System — Biomet Orthopedics, Inc. · Class II
Novation — Exactech, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class III
OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
BI-METRIC X-SERIES HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
Echo® Bi-Metric® Hip System — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K022403 also covers:

K023087 also covers:

K222056 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 e1789176-daee-4411-a57f-86d7d1bbf9d7 36 fields · synced May 30, 2026