FDA.reportPublic FDA data

MADISON

Primary DI
03607505403892
Brand
MADISON
Company
IMPLANET
Model
LB femoral stylus
Catalog number
540389
Published
2020-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607505403892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607505403892036075054038923607505403892

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
291993439
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03607505700755Jazz Spinal System5700755700752026-04-02
03607506310632Jazz Spinal System6310636310632026-04-02
03607506310656Jazz Spinal System6310656310652026-04-02
03607506310663Jazz Spinal System6310666310662026-04-02
03607506310779Jazz Spinal System6310776310772026-04-02
03607506313473Jazz Spinal System6313476313472026-04-02
03607506313527Jazz Spinal System6313526313522026-04-02
03607506317020Jazz Spinal System6317026317022026-04-02
03607506335932Jazz Spinal System6335932026-04-02
03607506340417Jazz Spinal System6340412026-04-02
03607506343623Jazz Spinal System6343622026-04-02
03607506343784Jazz Spinal System6343782026-04-02
03607506344569Jazz Spinal System6344562026-04-02
03607506344576Jazz Spinal System6344572026-04-02
03607506344583Jazz Spinal System6344582026-04-02
03607506344613Jazz Spinal System6344612026-04-02
03607506344620Jazz Spinal System6344622026-04-02
03607505700830Jazz Spinal System5700835700832025-11-28
03607506348512Jazz Spinal System6348512025-11-18
03607506348529Jazz Spinal System6348522025-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07613327000092INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000108INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000115INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000122INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000146INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000153INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000160INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000214INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000238INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000245INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000252INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000306INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000337INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000405INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000467INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000597INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327010107INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327010114INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327010121INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327013511TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013528TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013542TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013559TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013573TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327014488ScorpioHowmedica Osteonics Corp.JWH2015-09-24