MRH 6497-2-303

GUDID 07613327033786

Tibial Bearing Component

Howmedica Osteonics Corp.

Uncoated knee tibia prosthesis, polyethylene
Primary Device ID07613327033786
NIH Device Record Key5fae4808-a3bb-49b2-bc8d-d2a2439cb547
Commercial Distribution StatusIn Commercial Distribution
Brand NameMRH
Version Model Number6497-2-303
Catalog Number6497-2-303
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 Identifiers

Device Issuing AgencyDevice ID
GS107613327033786 [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 [MRH]

07613327101089Knee Tibial Baseplate
07613327101065Knee Tibial Baseplate
07613327101058Knee Tibial Baseplate
07613327101041Knee Tibial Baseplate
07613327050097MRH Knee Femoral Distal Block
07613327050080MRH Knee Femoral Distal Block
07613327050073MRH Knee Femoral Distal Block
07613327050066MRH Knee Femoral Distal Block
07613327050059MRH Knee Femoral Distal Block
07613327045376MRH Knee Femoral Component
07613327045338MRH Knee Tibial Baseplate
07613327045321MRH Knee Tibial Baseplate
07613327045314MRH Knee Tibial Baseplate
07613327045307MRH Knee Tibial Baseplate
07613327045291MRH Bushings, Sleeve, Neutral Bumper
07613327045284MRH Knee Tibial Sleeve
07613327045277MRH Knee Bumper Insert
07613327045260MRH Knee Bumper Insert
07613327045253Modular Rotating Hinge Knee-Axle
07613327045246MRH Knee Femoral Bushing
07613327045239MRH Tibial Bearing Component
07613327045222MRH Tibial Bearing Component
07613327045215MRH Tibial Rotating Component
07613327045208MRH Tibial Rotating Component
07613327045192MRH Knee Femoral Component
07613327045185MRH Knee Femoral Component
07613327045178MRH Knee Femoral Component
07613327045161MRH Knee Femoral Component
07613327045154MRH Knee Femoral Component
07613327045147MRH Knee Femoral Component
07613327045130MRH Knee Femoral Component
07613327045123MRH Knee Femoral Component
07613327045109MRH Knee Femoral Component
07613327043884MRH Knee Tibial Insert
07613327043860MRH Knee Tibial Insert
07613327043853MRH Knee Tibial Insert
07613327043846MRH Knee Tibial Insert
07613327043839MRH Knee Tibial Insert
07613327043822MRH Knee Tibial Insert
07613327043815MRH Knee Tibial Insert
07613327043808MRH Knee Tibial Insert
07613327043792MRH Knee Tibial Insert
07613327043785MRH Knee Tibial Insert
07613327043778MRH Tibial Bearing Component
07613327033786Tibial Bearing Component
07613327033762Tibial Bearing Component
07613327033755Tibial Bearing Component

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