FDA.reportPublic FDA data

Trident

Primary DI
04546540259936
Brand
Trident
Company
Howmedica Osteonics Corp.
Model
625-0T-36I
Catalog number
625-0T-36I
Device description
Alpha Code I
Published
2015-10-09
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
04546540259936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540259936045465402599364546540259936

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
07613327259797INSTRUMENT1100-2800R1100-2800R2016-09-24
07613327138078SOLAR5351-41085351-41082015-09-24
04546540167415EXETER0942-2-1100942-2-1102015-09-24
04546540167422EXETER0942-2-1120942-2-1122015-09-24
04546540167439EXETER0942-2-1140942-2-1142015-09-24
04546540167446EXETER0942-2-1160942-2-1162015-09-24
04546540167453EXETER0942-2-1180942-2-1182015-09-24
04546540167460EXETER0942-2-1200942-2-1202015-09-24
07613327245158INSTRUMENT6543-4-8186543-4-8182017-11-13
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26

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