MADISON 340259

GUDID 03607503402590

IMPLANET

Cruciate-retaining total knee prosthesis
Primary Device ID03607503402590
NIH Device Record Key07ffb6de-4d4a-48c9-bb9f-b688e8e0735d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMADISON
Version Model NumberUniversal UC insert Size 3 - 20 mm
Catalog Number340259
Company DUNS291993439
Company NameIMPLANET
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103607503402590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-18
Device Publish Date2020-03-10

On-Brand Devices [MADISON]

03607503400480Cemented CR femoral component S1 L
03607503403412Cemented CR femoral component S8 R
03607503403405Cemented CR femoral component S7 R
03607503403399Cemented CR femoral component S6 R
03607503403382Cemented CR femoral component S5 R
03607503403375Cemented CR femoral component S4 R
03607503403368Cemented CR femoral component S3 R
03607503403351Cemented CR femoral component S2 R
03607503403344Cemented CR femoral component S8 L
03607503403337Cemented CR femoral component S7 L
03607503403320Cemented CR femoral component S6 L
03607503403313Cemented CR femoral component S5 L
03607503403306Cemented CR femoral component S4 L
03607503403290Cemented CR femoral component S3 L
03607503403283Cemented CR femoral component S2 L
03607503400565Cemented CR femoral component S1 R
03607503402743Universal UC insert Size 8 - 20 mm
03607503402736Universal UC insert Size 8 - 18 mm
03607503402729Universal UC insert Size 8 - 16 mm
03607503402712Universal UC insert Size 7 - 20 mm
03607503402705Universal UC insert Size 7 - 18 mm
03607503402699Universal UC insert Size 7 - 16 mm
03607503402682Universal UC insert Size 6 - 20 mm
03607503402675Universal UC insert Size 6 - 18 mm
03607503402668Universal UC insert Size 6 - 16 mm
03607503402651Universal UC insert Size 5 - 20 mm
03607503402644Universal UC insert Size 5 - 18 mm
03607503402637Universal UC insert Size 5 - 16 mm
03607503402620Universal UC insert Size 4 - 20 mm
03607503402613Universal UC insert Size 4 - 18 mm
03607503402606Universal UC insert Size 4 - 16 mm
03607503402590Universal UC insert Size 3 - 20 mm
03607503402583Universal UC insert Size 3 - 18 mm
03607503402576Universal UC insert Size 3 - 16 mm
03607503402569Universal UC insert Size 2 - 20 mm
03607503402552Universal UC insert Size 2 - 18 mm
03607503402545Universal UC insert Size 2 - 16 mm
03607503402538Universal UC insert Size 1 - 20 mm
03607503402521Universal UC insert Size 1 - 18 mm
03607503402514Universal UC insert Size 1 - 16 mm
03607503402262Universal UC insert Size 8 - 14 mm
03607503402255Universal UC insert Size 8 - 12 mm
03607503402248Universal UC insert Size 8 - 10 mm
03607503402231Universal UC insert Size 7 - 14 mm
03607503402224Universal UC insert Size 7 - 12 mm
03607503402217Universal UC insert Size 7 - 10 mm
03607503402200Universal UC insert Size 6 - 14 mm
03607503402194Universal UC insert Size 6 - 12 mm
03607503402187Universal UC insert Size 6 - 10 mm
03607503402170Universal UC insert Size 5 - 14 mm

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