MDISON 540001

GUDID 03607505400013

IMPLANET

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID03607505400013
NIH Device Record Keycee884f8-2955-4c01-a35a-61ef29c87e8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMDISON
Version Model NumberTibial trial baseplate - S1
Catalog Number540001
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103607505400013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03607505400013]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-20
Device Publish Date2020-03-12

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03607506313374 - Jazz Spinal System2025-07-07 Straight rod 5.5x80
03607506313398 - Jazz Spinal System2025-07-07 Straight rod 5.5x90
03607506313411 - Jazz Spinal System2025-07-07 Straight rod 5.5x100
03607506313428 - Jazz Spinal System2025-07-07 Straight rod 5.5x110
03607506313435 - Jazz Spinal System2025-07-07 Straight rod 5.5x120

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