KNEETEC PFJ

GUDID 03700386937712

TORNIER

Polyethylene patella prosthesis

• Primary Device ID: 03700386937712
• NIH Device Record Key: 05aabe0f-d498-4994-bfc1-ec587d2aa219
• Commercial Distribution Discontinuation: 2017-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: KNEETEC PFJ
• Version Model Number: GDI119
• Company DUNS: 260324876
• Company Name: TORNIER
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700386937712 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111970

FDA Product Code

• KRR: PROSTHESIS, KNEE, PATELLO/FEMORAL, 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: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-10-16

Devices Manufactured by TORNIER

• 03700434015058 - Blueprint: 2024-10-07 Win
• 03700434015065 - Blueprint: 2024-10-07 Mac
• 03700434023824 - Blueprint Mixed Reality: 2024-08-13 HOLOBLUEPRINT™
• 03700434023176 - AEQUALIS REVERSED FRACTURE: 2024-07-04 Humeral Insert
• 03700434023183 - AEQUALIS REVERSED FRACTURE: 2024-07-04 Humeral Insert
• 03700434023190 - AEQUALIS REVERSED FRACTURE: 2024-07-04 Humeral Insert
• 03700434023695 - Shoulder iD: 2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
• 03700434023701 - Shoulder iD: 2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide