Trinity Acetabular Hip System with HXLPE Liners E321.040

GUDID 05055196937925

Trinity CoCr Modular Head Ø40mm SHORT -4.0mm 12/14 Eurocone Taper

CORIN LTD

Metallic femoral head prosthesis
Primary Device ID05055196937925
NIH Device Record Key21ac8a34-549f-4e64-9a47-fa3dc516c343
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Acetabular Hip System with HXLPE Liners
Version Model NumberE321.040
Catalog NumberE321.040
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
GS105055196937925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[05055196937925]

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 [Trinity Acetabular Hip System with HXLPE Liners]

05055343890448Screw Hole Depth Gauge
05055343886908FLEXIBLE DRILL DRIVER
05055343870839Suction Cup Bellows Type - TRINITY SPARE
05055343868683MODULAR SCREWDRIVER
05055343867655PE LINER EXTRACTOR
05055343866054LOCKABLE ANTEVERSION GUIDE
05055343865248MIS LINER INTRODUCER
05055343865231PUSHER/INTRODUCER
05055343865224STRAIGHT INTRODUCER/IMPACTOR HANDLE
05055343865217MIS PUSHER/INTRODUCER
05055343865101MODULAR UJ SCREWDRIVER
05055343865088MODULAR SCREWDRIVER BALL END
05055343827970ACETABULAR REAMER - Ø68mm
05055343827963ACETABULAR REAMER - Ø67mm
05055343827956ACETABULAR REAMER - Ø66mm
05055343827949ACETABULAR REAMER - Ø65mm
05055343827932ACETABULAR REAMER - Ø64mm
05055343827925ACETABULAR REAMER - Ø63mm
05055343827918ACETABULAR REAMER - Ø62mm
05055343827901ACETABULAR REAMER - Ø61mm
05055343827895ACETABULAR REAMER - Ø60mm
05055343827888ACETABULAR REAMER - Ø59mm
05055343827871ACETABULAR REAMER - Ø58mm
05055343827864ACETABULAR REAMER - Ø57mm
05055343827857ACETABULAR REAMER - Ø56mm
05055343827840ACETABULAR REAMER - Ø55mm
05055343827833ACETABULAR REAMER - Ø54mm
05055343827826ACETABULAR REAMER - Ø53mm
05055343827819ACETABULAR REAMER - Ø52mm
05055343827802ACETABULAR REAMER - Ø51mm
05055343827796ACETABULAR REAMER - Ø50mm
05055343827789ACETABULAR REAMER - Ø49mm
05055343827772ACETABULAR REAMER - Ø48mm
05055343827765ACETABULAR REAMER - Ø47mm
05055343827758ACETABULAR REAMER - Ø46mm
05055343827741ACETABULAR REAMER - Ø45mm
05055343827734ACETABULAR REAMER - Ø44mm
05055343827727ACETABULAR REAMER - Ø43mm
05055343827710ACETABULAR REAMER - Ø42mm
05055343827703ACETABULAR REAMER - Ø41mm
05055343827697ACETABULAR REAMER - Ø40mm
05055343827680ACETABULAR REAMER - Ø39mm
05055343827673ACETABULAR REAMER - Ø38mm
05055343827659STRAIGHT REAMER DRIVE HANDLE - AO DRIVE
05055343827079DRIVE ADAPTOR - AO MALE TO HUDSON/JACOBS MALE
05055196972681LINER IMPACTOR. SIZE 40mm
05055196972674LINER IMPACTOR. SIZE 36mm
05055196972650LINER IMPACTOR. SIZE 28mm
05055196971868MIS INTRODUCER/IMPACTOR HANDLE
05055196971851Trinity Liner (HXLPE) Ø40mm Neutral 4mm EPW Taper Size 5
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