Entrada Hip Stem

GUDID 00822409036103

Size 12 EXT Collarless

Ortho Development Corporation

Coated hip femur prosthesis, modular
Primary Device ID00822409036103
NIH Device Record Key0717ffa8-1225-47f5-8ab8-bb5917ab49a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameEntrada Hip Stem
Version Model Number510-1012
Company DUNS876542390
Company NameOrtho Development Corporation
Device Count1
DM Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409036103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, 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 Date2017-08-29

On-Brand Devices [Entrada Hip Stem]

00822409036325Size 21 EXT Collar
00822409036318Size 20 EXT Collar
00822409036301Size 19 EXT Collar
00822409036295Size 18 EXT Collar
00822409036288Size 17 EXT Collar
00822409036271Size 16 EXT Collar
00822409036264Size 15 EXT Collar
00822409036257Size 14 EXT Collar
00822409036240Size 13 EXT Collar
00822409036233Size 12 EXT Collar
00822409036226Size 11 EXT Collar
00822409036219Size 10 EXT Collar
00822409036202Size 9 EXT Collar
00822409036196Size 21 EXT Collarless
00822409036189Size 20 EXT Collarless
00822409036172Size 19 EXT Collarless
00822409036165Size 18 EXT Collarless
00822409036158Size 17 EXT Collarless
00822409036141Size 16 EXT Collarless
00822409036134Size 15 EXT Collarless
00822409036127Size 14 EXT Collarless
00822409036110Size 13 EXT Collarless
00822409036103Size 12 EXT Collarless
00822409036097Size 11 EXT Collarless
00822409036080Size 10 EXT Collarless
00822409036073Size 9 EXT Collarless
00822409036066Size 21 STD Collar
00822409036059Size 20 STD Collar
00822409036042Size 19 STD Collar
00822409036035Size 18 STD Collar
00822409036028Size 17 STD Collar
00822409036011Size 16 STD Collar
00822409036004Size 15 STD Collar
00822409035991Size 14 STD Collar
00822409035984Size 13 STD Collar
00822409035977Size 12 STD Collar
00822409035960Size 11 STD Collar
00822409035953Size 10 STD Collar
00822409035946Size 9 STD Collar
00822409035939Size 8 STD Collar
00822409035922Size 21 STD Collarless
00822409035915Size 20 STD Collarless
00822409035908Size 19 STD Collarless
00822409035892Size 18 STD Collarless
00822409035885Size 17 STD Collarless
00822409035878Size 16 STD Collarless
00822409035861Size 15 STD Collarless
00822409035854Size 14 STD Collarless
00822409035847Size 13 STD Collarless
00822409035830Size 12 STD Collarless

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