FDA.reportPublic FDA data

Trident

Primary DI
04546540516879
Brand
Trident
Company
Howmedica Osteonics Corp.
Model
625-0T-36H
Catalog number
625-0T-36H
Device description
Alpha Code H
Published
2014-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRAProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or UncementedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000013001
P000013002
P000013003
P000013004
P000013005
P000013006
P000013008
P000013009
P000013010
P000013011
P000013012
P000013013
P000013014
P000013015
P000013016
P000013017
P000013018
P000013019
P000013022

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000013001TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013002TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013003TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013004TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013005TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013006TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013008TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013009TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013010TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013011TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013012TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013013TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013014TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013015TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013016TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013017TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013018TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013019TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA
P000013022TRIDENT SYSTEMHowmedica Osteonics Corp.2003-02-03MRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540516879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540516879045465405168794546540516879

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic acetabular linerA sterile implantable inner 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 ceramic material (e. g alumina).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Lumen/Inner Diameter36Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327036503Triathlon5585-C-0165585-C-0162015-09-24
07613327036510Triathlon5585-C-0205585-C-0202015-09-24
07613327036527Triathlon5585-C-0255585-C-0252015-09-24
07613327036534Triathlon5585-C-0305585-C-0302015-09-24
07613327036541Triathlon5585-C-0355585-C-0352015-09-24
07613327036558Triathlon5585-C-0405585-C-0402015-09-24
07613327036565Triathlon5585-C-0455585-C-0452015-09-24
07613327036572Triathlon5585-C-0505585-C-0502015-09-24
07613327036589Triathlon5585-C-0555585-C-0552015-09-24
07613327036596Triathlon5585-C-0605585-C-0602015-09-24
07613327041071Triathlon5520-M-1005520-M-1002015-09-24
07613327041095Triathlon5520-M-2005520-M-2002015-09-24
07613327041101Triathlon5520-M-3005520-M-3002015-09-24
07613327041118Triathlon5520-M-4005520-M-4002015-09-24
07613327041125Triathlon5520-M-5005520-M-5002015-09-24
07613327041132Triathlon5520-M-6005520-M-6002015-09-24
07613327041149Triathlon5520-M-7005520-M-7002015-09-24
07613327041156Triathlon5520-M-8005520-M-8002015-09-24
07613327041392Triathlon5527-B-1005527-B-1002015-09-24
07613327041408Triathlon5527-B-3005527-B-3002015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M684PLS0R4111ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4121ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4131ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4141ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4161ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0S4101ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4101ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4151ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684260000041LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000051LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000061LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000071LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000081LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000091LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000101LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000111LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000121LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000131LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000141LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000151LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800461LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800481LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800501LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800521LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800541LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800561LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800581LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800601LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800621LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800641LineageMicroport Orthopedics Inc.MRA2016-08-31