FDA.reportPublic FDA data

Truliant

Primary DI
10885862618214
Brand
Truliant
Company
Exactech, Inc.
Model
SPI-046319
Catalog number
SPI-046319
Published
2022-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862618214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586261821410885862618214

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument surgical connectorA small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862656117Newton02-521-90-200402-521-90-20042026-05-27
10885862656124Newton02-521-90-200502-521-90-20052026-05-27
10885862656131Newton02-521-90-200602-521-90-20062026-05-27
10885862656148Newton02-521-90-200702-521-90-20072026-05-27
10885862656155Newton02-521-90-200802-521-90-20082026-05-27
10885862656162Newton02-521-90-200902-521-90-20092026-05-27
10885862656179Newton02-521-90-201002-521-90-20102026-05-27
10885862653697Alteon190-00-01190-00-012026-05-26
10885862653703Alteon190-00-02190-00-022026-05-26
10885862653710Alteon190-00-03190-00-032026-05-26
10885862653727Alteon190-00-04190-00-042026-05-26
10885862653734Alteon190-00-05190-00-052026-05-26
10885862653741Alteon190-00-06190-00-062026-05-26
10885862653758Alteon190-00-07190-00-072026-05-26
10885862653765Alteon190-00-08190-00-082026-05-26
10885862653772Alteon190-00-09190-00-092026-05-26
10885862653789Alteon190-00-10190-00-102026-05-26
10885862653796Alteon190-00-11190-00-112026-05-26
10885862653802Alteon190-00-12190-00-122026-05-26
10885862653819Alteon190-00-13190-00-132026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327014846TriathlonHowmedica Osteonics Corp.MBH2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000023INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000030INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000047INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000054INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000061INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000078INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000085INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000092INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000108INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000115INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000122INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000139INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000146INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000153INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000160INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000177INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000184INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000191INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000207INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000214INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000221INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000238INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000245INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000252INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000269INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000276INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000290INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000306INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24