Unity Total Knee System 1236146

GUDID 05055343899748

Distal Femoral Augment Trial 10 mm

CORIN LTD

Knee femur prosthesis trial

• Primary Device ID: 05055343899748
• NIH Device Record Key: 1b695f17-c359-43b8-b706-0891e4ff31eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unity Total Knee System
• Version Model Number: 1236146
• Catalog Number: 1236146
• Company DUNS: 295437313
• Company Name: CORIN LTD
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055343899748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173884

FDA Product Code

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

Sterilization

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

[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 Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-10-12

On-Brand Devices [Unity Total Knee System]

• 05056139233760: Hole Saw Guide
• 05056139233753: Hole Saw
• 05056139233746: Threaded Collarless Pin Long
• 05056139233739: Unity ASC IM Rod
• 05056139233722: Universal Impactor
• 05056139233715: Extraction Tool
• 05056139233708: Unity ASC Modular Handle
• 05056139233227: Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick
• 05056139233210: Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick
• 05056139233203: Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick
• 05056139233197: Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick
• 05056139233180: Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick
• 05056139233173: Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick
• 05056139233166: Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick
• 05056139233159: Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick
• 05056139233142: Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick
• 05056139233128: Unity ASC Size 8 Tibial Template Trial
• 05056139233111: Unity ASC Size 7 Tibial Template Trial
• 05056139233104: Unity ASC Size 6 Tibial Template Trial
• 05056139233098: Unity ASC Size 5 Tibial Template Trial
• 05056139233081: Unity ASC Size 4 Tibial Template Trial
• 05056139233036: Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick
• 05056139232978: Unity ASC Femoral PS Saw Resection Guide Std
• 05056139232961: Unity ASC Femoral PS Insert Macro
• 05056139232879: Patella Caliper
• 05056139232688: Down Rod
• 05056139232657: Tibial Stylus
• 05056139232640: 3in1 Block
• 05056139232633: Ankle Clamp & ML Guide
• 05056139232626: Up Rod
• 05056139232596: Pin Puller
• 05056139232589: Femoral Introducer Impactor Head
• 05056139232572: Distal Resection Guide
• 05056139232565: Femoral Introducer
• 05056139232558: Patella Drill Guide Dome Sz 4 & 5
• 05056139232541: Patella Drill Guide Dome Sz 1 to 3
• 05056139232534: Patella Drill Guide Offset Dome Sz 3 & 4
• 05056139232527: Patella Drill Guide Offset Dome Sz 1 & 2
• 05056139232510: Patella Cement Clamp
• 05056139232503: Patella Clamp
• 05056139232237: Tibial Cutting Block Right
• 05056139232220: Tibial Cutting Block Left
• 05056139231568: Femoral / Tibial Augment Screw 5 mm
• 05056139231476: Torque Indicator
• 05056139231469: 2.5 m Allen Key
• 05056139231360: Tibial Augment Trial RL-LM Size 9
• 05056139231353: Tibial Augment Trial RL-LM Size 8
• 05056139231346: Tibial Augment Trial RL-LM Size 7
• 05056139231339: Tibial Augment Trial RL-LM Size 6
• 05056139231322: Tibial Augment Trial RL-LM Size 5