GMRS 6495-5-018

GUDID 07613327033557

Straight Fluted Press-Fit Stem

Howmedica Osteonics Corp.

Press-fit femoral stem prosthesis

Primary Device ID	07613327033557
NIH Device Record Key	191606d8-7b1a-411d-8c17-e720928e6053
Commercial Distribution Status	In Commercial Distribution
Brand Name	GMRS
Version Model Number	6495-5-018
Catalog Number	6495-5-018
Company DUNS	058311945
Company Name	Howmedica Osteonics Corp.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter
Device Size Text, specify	0
Length	125 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327033557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K022403

FDA Product Code

KRO	PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-24

On-Brand Devices [GMRS]

07613327142631	Distal Femoral Growing Prosthesis
07613327142624	Distal Femoral Growing Prosthesis
07613327142617	Distal Femoral Growing Prosthesis
07613327142600	Distal Femoral Growing Prosthesis
07613327142594	Distal Femoral Growing Prosthesis
07613327142587	Distal Femoral Growing Prosthesis
07613327142570	Distal Femoral Growing Prosthesis
07613327142563	Distal Femoral Growing Prosthesis
07613327142556	Distal Femoral Growing Prosthesis
07613327142549	Distal Femoral Growing Prosthesis
07613327142532	Distal Femoral Growing Prosthesis
07613327142525	Distal Femoral Growing Prosthesis
07613327049831	Extension Piece
07613327049824	Distal Femoral Component
07613327049800	Proximal Femoral Component
07613327049299	Extension Piece
07613327049282	Extension Piece
07613327049275	Extension Piece
07613327049268	Extension Piece
07613327049251	Extension Piece
07613327049244	Extension Piece
07613327049237	Extension Piece
07613327049220	Extension Piece
07613327049213	Connection Piece
07613327049206	Extension Piece
07613327049190	Extension Piece
07613327049176	Connection Piece
07613327049169	Extension Piece
07613327049152	Extension Piece
07613327049145	Connection Piece
07613327049121	Connection Piece
07613327048919	Proximal Tibia
07613327048896	Tibial Rotating Component
07613327048865	Proximal Tibia
07613327048858	Insert for Small Proximal Tibial Component
07613327048841	Bushing for Small Distal Femur
07613327048834	Insert for Small Proximal Tibial Component
07613327048827	Insert for Small Proximal Tibial Component
07613327048810	Insert for Small Proximal Tibial Component
07613327048803	Insert for Small Proximal Tibial Component
07613327048797	Distal Femoral Component
07613327048780	Distal Femoral Component
07613327048773	Axle
07613327048766	Proximal Femoral Component
07613327048759	Distal Femoral Component
07613327048735	Proximal Femoral Component
07613327048728	Proximal Femoral Component
07613327048711	Proximal Femoral Component
07613327048704	Proximal Femoral Component
07613327033748	Bowed Press-Fit Stem

Trademark Results [GMRS]

Mark Image Registration \| Serial	Company Trademark Application Date
GMRS 78901513 3222949 Live/Registered	CHEVRON INTELLECTUAL PROPERTY LLC 2006-06-06
GMRS 78186568 2921512 Live/Registered	HOWMEDICA OSTEONICS CORP. 2002-11-19