PHYSICA 6522.15.040

GUDID 08033390092678

Tibial Plate #4

LIMACORPORATE SPA

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 08033390092678
• NIH Device Record Key: 3a17fb98-7f8d-4ee1-990a-7ea6598a5a54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHYSICA
• Version Model Number: Fixed Tibial Plate
• Catalog Number: 6522.15.040
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390092678 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141934

FDA Product Code

• HRY: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-08-04

On-Brand Devices [PHYSICA]

• 08033390092715: Tibial Plate #9
• 08033390092708: Tibial Plate #8
• 08033390092692: Tibial Plate #7
• 08033390092685: Tibial Plate #6
• 08033390092678: Tibial Plate #4
• 08033390092661: Tibial Plate #2
• 08033390089937: Tibial Plate #10
• 08033390089920: Tibial Plate #5
• 08033390088367: Tibial Plate #3
• 08033390088350: Tibial Plate #1
• 08033390088527: Tibial stem h. 60mm
• 08033390088510: Tibial stem h. 40mm
• 08033390088398: Tibial stem h. 20mm
• 08033390091046: Patellar prosthesis dia. 41mm
• 08033390091039: Patellar prosthesis dia. 38mm
• 08033390091022: Patellar prosthesis dia. 35mm
• 08033390091015: Patellar prosthesis dia. 32mm
• 08033390091008: Patellar prosthesis dia. 29mm
• 08033390088404: Patellar prosthesis dia. 26mm
• 08033390110549: PHYSICA - Patellar Caliper