Trinity Acetabular Hip System with ECiMa Liners

Primary DI
05055343869741
Brand
Trinity Acetabular Hip System with ECiMa Liners
Company
CORIN LTD
Model
322.03.832
Catalog number
322.03.832
Device description
Trinity Liner (ECIMA) Ø32mm +4mm Oblique Taper Size 3
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
OQIHip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111481000CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERSCorin USA2012-02-06OQI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055343869741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055343869741050553438697415055343869741

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+441285659866rachel.king@coringroup.com
+441285659866lucinda.gerber@coringroup.com

Regulatory Flags#

DUNS number
295437313
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056139244933Apollo KneeTKR.BB.14022025-04-07
05056139244940Apollo KneeTKR.BB.14032025-04-07
05056139244971Apollo KneeTKR.IN.16002025-04-07
05056139244988Apollo KneeTKR.IN.17002025-04-07
05056139244995Apollo KneeTKR.BB.17002025-04-07
05056139245008Apollo KneeTKR.BB.17012025-04-07
05056139245015Apollo KneeTKR.BB.17022025-04-07
05056139245022Apollo KneeTKR.BB.17032025-04-07
05056139245039Apollo KneeTKR.BB.17042025-04-07
05056139245053Apollo KneeTKR.BB.17052025-04-07
05056139245060Apollo KneeTKR.BB.17062025-04-07
05056139245077Apollo KneeTKR.BB.17072025-04-07
05056139245145Apollo KneeTKR.IN.18002025-04-07
05056139245176Apollo KneeTKR.BB.15002025-04-07
05056139245718Apollo KneeTKR.IN.14002025-04-07
05056139245770Apollo KneeTKR.BB.11002025-04-07
05056139245787Apollo KneeTKR.BB.11012025-04-07
05056139245794Apollo KneeTKR.BB.11022025-04-07
05056139245800Apollo KneeTKR.BB.11032025-04-07
05056139245817Apollo KneeTKR.BB.12002025-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07611996118674POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142327POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142334POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142341POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142358POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142372POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.LZO2017-01-12
07611996142396POLARSTEMSmith & Nephew, Inc.LZO2016-09-01
07611996142396POLARSTEMSmith & Nephew, Inc.MEH2016-09-01
07611996074918SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075007SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075038SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095586SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095593SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095609SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095616SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095623SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095630SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095647SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996095654SLR-PLUSSmith & Nephew, Inc.LZO2016-08-19