Cenator Total Hip System 116.126

GUDID 05055196912601

MOD HEAD STD NECK

CORIN LTD

Metallic femoral head prosthesis
Primary Device ID05055196912601
NIH Device Record Keyfe346daa-8165-4bcf-8653-162946c62e27
Commercial Distribution StatusIn Commercial Distribution
Brand NameCenator Total Hip System
Version Model Number116.126
Catalog Number116.126
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
Emaillucinda.gerber@coringroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055196912601 [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

[05055196912601]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2016-08-17

On-Brand Devices [Cenator Total Hip System]

05055196988750CENATOR CUP 28MM ID
05055196968622MOD HEAD LONG NECK
05055196957992CENATOR CUP
05055196957985CENATOR CUP
05055196957978CENATOR CUP
05055196957954CENATOR CUP
05055196957947CENATOR CUP
05055196957770DOUBLE TROCHANTER WI
05055196957756CENATOR CUP FLANGED
05055196957749CENATOR CUP FLANGED
05055196957732CENATOR CUP FLANGED
05055196957725CENATOR CUP 28MM ID
05055196957718CENATOR CUP 28MM ID
05055196957701CENATOR CUP 28MM ID
05055196957572CENATOR STEM
05055196957565CENATOR STEM
05055196957541CENATOR STEM
05055196957534CENATOR STEM
05055196957497CENATOR STEM
05055196957480CENATOR STEM
05055196957473CENATOR STEM
05055196957466CENATOR STEM
05055196957459CENATOR STEM
05055196939981CENATOR CUP
05055196939967CENATOR CUP
05055196939943CENATOR CUP
05055196939929CENATOR CUP
05055196928817MOD ENDO HEAD LONG N
05055196928800MOD ENDO HEAD LONG N
05055196928794MOD ENDO HEAD LONG N
05055196913400MOD HEAD SHORT NECK
05055196913394MOD HEAD STD NECK
05055196912892MOD HEAD SHORT NECK
05055196912885MOD HEAD SHORT NECK
05055196912878MOD HEAD SHORT NECK
05055196912618MOD HEAD STD NECK
05055196912601MOD HEAD STD NECK
05055196912595MOD HEAD STD NECK
05055196912335MOD HEAD LONG NECK
05055196912328MOD HEAD LONG NECK
05055196912311MOD HEAD LONG NECK

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