MDISON 540001

GUDID 03607505400013

IMPLANET

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03607505400013
• NIH Device Record Key: cee884f8-2955-4c01-a35a-61ef29c87e8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MDISON
• Version Model Number: Tibial trial baseplate - S1
• Catalog Number: 540001
• Company DUNS: 291993439
• Company Name: IMPLANET
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607505400013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192084

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03607505400013]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-20
• Device Publish Date: 2020-03-12

Devices Manufactured by IMPLANET

• 03607503800006 - SQUALE: 2023-06-14 Anterior Cervical Cage W14 x D13 x H04, 4°
• 03607503800013 - SQUALE: 2023-06-14 Anterior Cervical Cage W14 x D13 x H05, 4°
• 03607503800020 - SQUALE: 2023-06-14 Anterior Cervical Cage W14 x D13 x H06, 4°
• 03607503800037 - SQUALE: 2023-06-14 Anterior Cervical Cage W14 x D13 x H07, 4°
• 03607503800044 - SQUALE: 2023-06-14 Anterior Cervical Cage W14 x D13 x H08, 4°
• 03607503800051 - SQUALE: 2023-06-14 Anterior Cervical Cage W14 x D13 x H09, 4°
• 03607503800068 - SQUALE: 2023-06-14 Anterior Cervical Cage W17 x D13 x H04, 4°
• 03607503800075 - SQUALE: 2023-06-14 Anterior Cervical Cage W17 x D13 x H05, 4°