GMRS 6495-3-601

GUDID 07613327048896

Tibial Rotating Component

Howmedica Osteonics Corp.

Uncoated knee tibia prosthesis, metallic
Primary Device ID07613327048896
NIH Device Record Keyfcfef72b-d657-4cd1-b2bf-e4e45fcb1216
Commercial Distribution StatusIn Commercial Distribution
Brand NameGMRS
Version Model Number6495-3-601
Catalog Number6495-3-601
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327048896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2015-09-24

On-Brand Devices [GMRS]

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

Trademark Results [GMRS]

Mark Image

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

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