Unity Total Knee System 1236146

GUDID 05055343899748

Distal Femoral Augment Trial 10 mm

CORIN LTD

Knee femur prosthesis trial
Primary Device ID05055343899748
NIH Device Record Key1b695f17-c359-43b8-b706-0891e4ff31eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnity Total Knee System
Version Model Number1236146
Catalog Number1236146
Company DUNS295437313
Company NameCORIN LTD
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105055343899748 [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

[05055343899748]

Moist Heat or Steam Sterilization


[05055343899748]

Moist Heat or Steam Sterilization


[05055343899748]

Moist Heat or Steam Sterilization


[05055343899748]

Moist Heat or Steam Sterilization


[05055343899748]

Moist Heat or Steam Sterilization


[05055343899748]

Moist Heat or Steam Sterilization


[05055343899748]

Moist Heat or Steam Sterilization


[05055343899748]

Moist Heat or Steam Sterilization


[05055343899748]

Moist Heat or Steam Sterilization


[05055343899748]

Moist Heat or Steam Sterilization


[05055343899748]

Moist Heat or Steam Sterilization


[05055343899748]

Moist Heat or Steam Sterilization


[05055343899748]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-07
Device Publish Date2018-10-12

On-Brand Devices [Unity Total Knee System]

05056139233760Hole Saw Guide
05056139233753Hole Saw
05056139233746Threaded Collarless Pin Long
05056139233739Unity ASC IM Rod
05056139233722Universal Impactor
05056139233715Extraction Tool
05056139233708Unity ASC Modular Handle
05056139233227Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick
05056139233210Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick
05056139233203Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick
05056139233197Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick
05056139233180Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick
05056139233173Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick
05056139233166Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick
05056139233159Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick
05056139233142Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick
05056139233128Unity ASC Size 8 Tibial Template Trial
05056139233111Unity ASC Size 7 Tibial Template Trial
05056139233104Unity ASC Size 6 Tibial Template Trial
05056139233098Unity ASC Size 5 Tibial Template Trial
05056139233081Unity ASC Size 4 Tibial Template Trial
05056139233036Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick
05056139232978Unity ASC Femoral PS Saw Resection Guide Std
05056139232961Unity ASC Femoral PS Insert Macro
05056139232879Patella Caliper
05056139232688Down Rod
05056139232657Tibial Stylus
050561392326403in1 Block
05056139232633Ankle Clamp & ML Guide
05056139232626Up Rod
05056139232596Pin Puller
05056139232589Femoral Introducer Impactor Head
05056139232572Distal Resection Guide
05056139232565Femoral Introducer
05056139232558Patella Drill Guide Dome Sz 4 & 5
05056139232541Patella Drill Guide Dome Sz 1 to 3
05056139232534Patella Drill Guide Offset Dome Sz 3 & 4
05056139232527Patella Drill Guide Offset Dome Sz 1 & 2
05056139232510Patella Cement Clamp
05056139232503Patella Clamp
05056139232237Tibial Cutting Block Right
05056139232220Tibial Cutting Block Left
05056139231568Femoral / Tibial Augment Screw 5 mm
05056139231476Torque Indicator
050561392314692.5 m Allen Key
05056139231360Tibial Augment Trial RL-LM Size 9
05056139231353Tibial Augment Trial RL-LM Size 8
05056139231346Tibial Augment Trial RL-LM Size 7
05056139231339Tibial Augment Trial RL-LM Size 6
05056139231322Tibial Augment Trial RL-LM Size 5

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