KNEETEC PFJ

GUDID 03700386937712

TORNIER

Polyethylene patella prosthesis
Primary Device ID03700386937712
NIH Device Record Key05aabe0f-d498-4994-bfc1-ec587d2aa219
Commercial Distribution Discontinuation2017-11-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameKNEETEC PFJ
Version Model NumberGDI119
Company DUNS260324876
Company NameTORNIER
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com
Phone+330476613500
Emailorder@tornier.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS103700386937712 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-02-05
Device Publish Date2015-10-16

Devices Manufactured by TORNIER

03700434023176 - AEQUALIS REVERSED FRACTURE2024-07-04 Humeral Insert
03700434023183 - AEQUALIS REVERSED FRACTURE2024-07-04 Humeral Insert
03700434023190 - AEQUALIS REVERSED FRACTURE2024-07-04 Humeral Insert
03700434023695 - Shoulder iD2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
03700434023701 - Shoulder iD2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
03700434023718 - Shoulder iD2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
03700434023725 - Shoulder iD2024-05-31 BLUEPRINT Primary Reversed Glenoid Guide
03700434023732 - Shoulder iD2024-05-31 BLUEPRINT Primary Reversed Bone Model

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