Modular Elbow 6487-C-035

GUDID 07613327139204

Total Humeral Component

Howmedica Osteonics Corp.

Coated elbow humerus prosthesis
Primary Device ID07613327139204
NIH Device Record Key55ad3640-1796-4825-9614-374be7970660
Commercial Distribution StatusIn Commercial Distribution
Brand NameModular Elbow
Version Model Number6487-C-035
Catalog Number6487-C-035
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

Length35 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327139204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [Modular Elbow]

07613327139303Humeral Assembly
07613327139266Bearing, Bushing and Axle Kit
07613327139211Humeral Assembly
07613327139204Total Humeral Component
07613327139198Humeral Assembly
07613327139181Humeral Assembly
07613327139167Total Humeral Component
07613327138498Ulna Component
07613327138481Ulna Component
07613327138474Ulna Component
07613327138467Ulna Component
07613327138450Ulna Component
07613327138412Ulna Component

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