TaperFit Cemented Hip System 588.5000

GUDID 05055343871089

TaperFit Hip Stem 50mm Offset Large Stem size 0

CORIN LTD

Uncoated hip femur prosthesis, modular
Primary Device ID05055343871089
NIH Device Record Keya459e729-0dc3-4276-8f37-89192cd85803
Commercial Distribution StatusIn Commercial Distribution
Brand NameTaperFit Cemented Hip System
Version Model Number588.5000
Catalog Number588.5000
Company DUNS295437313
Company NameCORIN LTD
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+441285659866
Emailrachel.king@coringroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055343871089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[05055343871089]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-17

On-Brand Devices [TaperFit Cemented Hip System]

05055343892619Size 4 50mm Offset Rasp
05055343892602Size 3 50mm Offset Rasp
05055343892596Size 2 50mm Offset Rasp
05055343892589Size 1 50mm Offset Rasp
05055343892572Size 0 50mm Offset Rasp
05055343892565Size 4 45mm Offset Rasp
05055343892558Size 3 45mm Offset Rasp
05055343892541Size 2 45mm Offset Rasp
05055343892534Size 1 45mm Offset Rasp
05055343892527Size 0 45mm Offset Rasp
05055343892510Size 4 38mm Offset Rasp
05055343892503Size 3 38mm Offset Rasp
05055343892497Size 2 38mm Offset Rasp
05055343892480Size 1 38mm Offset Rasp
05055343892473Size 0 38mm Offset Rasp
05055343892466CDH Rasp
05055343892282Cement Restrictor Introducer
05055343888056FEMORAL CANAL OCCLUDER INTRODUCER
05055343885079MODULAR HEAD TRIAL Ø28mm/+7/XL(12/14)
05055343885062MODULAR HEAD TRIAL Ø40mm/-8/XS(12/14)
05055343885055MODULAR HEAD TRIAL Ø36mm/-8/XS(12/14)
05055343885048MODULAR HEAD TRIAL Ø32mm/-6/XS(12/14)
05055343885031MODULAR HEAD TRIAL Ø28mm/-5/XS(12/14)
050553438837788mm DISTAL DRILL
05055343883723MODULAR BOX OSTEOTOME
05055343878439STEM PUSHER
05055343871126TaperFit Hip Stem 50mm Offset Large Stem size 4
05055343871119TaperFit Hip Stem 50mm Offset Large Stem size 3
05055343871102TaperFit Hip Stem 50mm Offset Large Stem size 2
05055343871096TaperFit Hip Stem 50mm Offset Large Stem size 1
05055343871089TaperFit Hip Stem 50mm Offset Large Stem size 0
05055343871072TaperFit Hip Stem 45mm Offset Standard Stem size 0
05055343871065TaperFit Hip Stem 38mm Offset Narrow Stem size 0
0505534387104150mm OFFSET RASP SIZE 4
0505534387103450mm OFFSET RASP SIZE 3
0505534387102750mm OFFSET RASP SIZE 2
0505534387101050mm OFFSET RASP SIZE 1
0505534387100350mm OFFSET RASP SIZE 0
0505534387099045mm OFFSET RASP SIZE 0
0505534387098338mm OFFSET RASP SIZE 0
05055343870174Ø20/Ø22mm RESTRICTOR SIZER
05055343870167Ø16/Ø18mm RESTRICTOR SIZER
05055343870150Ø12/Ø14mm RESTRICTOR SIZER
05055343870143Ø8/Ø10mm RESTRICTOR SIZER
05055343868843TRIAL NECK
0505534386883645mm OFFSET RASP SIZE 4
0505534386882945mm OFFSET RASP SIZE 3
0505534386881245mm OFFSET RASP SIZE 2
0505534386880545mm OFFSET RASP SIZE 1
0505534386879938mm OFFSET RASP SIZE 4

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