Avenger Modular Radial Head Implant

GUDID 00817906028843

Head Component, +4 24 mm

IN2BONES USA, LLC

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Primary Device ID00817906028843
NIH Device Record Key5541c56e-75cb-4560-845e-6bf9b2e6472e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvenger Modular Radial Head Implant
Version Model NumberM70 HC224
Company DUNS079700711
Company NameIN2BONES USA, LLC
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 Usefalse
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
GS100817906028843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWIProsthesis, Elbow, Hemi-, Radial, Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-02
Device Publish Date2020-02-21

On-Brand Devices [Avenger Modular Radial Head Implant]

00817906028942Stem Component, Long 9.5 mm
00817906028935Stem Component, Long 8.5 mm
00817906028928Stem Component, Long 7.5 mm
00817906028911Stem Component, Long 6.5 mm
00817906028904Stem Component, Long 5.5 mm
00817906028898Stem Component, Standard 9.5 mm
00817906028881Stem Component, Standard 8.5 mm
00817906028874Stem Component, Standard 7.5 mm
00817906028867Stem Component, Standard 6.5 mm
00817906028850Stem Component, Standard 5.5 mm
00817906028843Head Component, +4 24 mm
00817906028836Head Component, +2 24 mm
00817906028829Head Component, 24 mm
00817906028812Head Component, +4 22 mm
00817906028805Head Component, +2 22 mm
00817906028799Head Component, 22 mm
00817906028782Head Component, +4 20 mm
00817906028775Head Component, +2 20 mm
00817906028768Head Component, 20 mm
00817906028751Head Component, +4 18 mm
00817906028744Head Component, +2 18 mm
00817906028737Head Component, 18 mm

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