GMK Revision Total Knee System

GUDID 07630030822162

Femoral wedge distal 4mm, size 3

Medacta International SA

Knee arthroplasty wedge

• Primary Device ID: 07630030822162
• NIH Device Record Key: 52041042-8b61-4fb0-aba6-de091beb31e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMK Revision Total Knee System
• Version Model Number: 02.07.304FDW
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07630030822162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102437

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-11-18

On-Brand Devices [GMK Revision Total Knee System]

• 07630030823190: Cemented Extension stem Ø16mm, 105mm
• 07630030823183: Cemented Extension stem Ø16mm, 65mm
• 07630030823176: Cemented Extension stem Ø13mm, 105mm
• 07630030823169: Cemented Extension stem Ø13mm, 65mm
• 07630030823152: Cemented Extension stem Ø11mm, 105mm
• 07630030823145: Cemented Extension stem Ø11mm, 65mm
• 07630030823138: Fluted Extension stem Ø22mm, 150mm
• 07630030823121: Fluted Extension stem Ø22mm, 105mm
• 07630030823114: Fluted Extension stem Ø22mm, 65mm
• 07630030823107: Fluted Extension stem Ø20mm, 150mm
• 07630030823091: Fluted Extension stem Ø20mm, 105mm
• 07630030823084: Fluted Extension stem Ø20mm, 65mm
• 07630030823077: Fluted Extension stem Ø18mm, 150mm
• 07630030823060: Fluted Extension stem Ø18mm, 105mm
• 07630030823053: Fluted Extension stem Ø18mm, 65mm
• 07630030823046: Fluted Extension stem Ø16mm, 150mm
• 07630030823039: Fluted Extension stem Ø16mm, 105mm
• 07630030823022: Fluted Extension stem Ø16mm, 65mm
• 07630030823015: Fluted Extension stem Ø15mm, 150mm
• 07630030823008: Fluted Extension stem Ø15mm, 105mm
• 07630030822995: Fluted Extension stem Ø15mm, 65mm
• 07630030822988: Fluted Extension stem Ø14mm, 150mm
• 07630030822971: Fluted Extension stem Ø14mm, 105mm
• 07630030822964: Fluted Extension stem Ø14mm, 65mm
• 07630030822957: Fluted Extension stem Ø13mm, 150mm
• 07630030822940: Fluted Extension stem Ø13mm, 105mm
• 07630030822933: Fluted Extension stem Ø13mm, 65mm
• 07630030822926: Fluted Extension stem Ø12mm, 150mm
• 07630030822919: Fluted Extension stem Ø12mm, 105mm
• 07630030822902: Fluted Extension stem Ø12mm, 65mm
• 07630030822896: Fluted Extension stem Ø11mm, 150mm
• 07630030822889: Fluted Extension stem Ø11mm, 105mm
• 07630030822872: Fluted Extension stem Ø11mm, 65mm
• 07630030822865: Fluted Extension stem Ø10mm, 150mm
• 07630030822858: Fluted Extension stem Ø10mm, 105mm
• 07630030822841: Fluted Extension stem Ø10mm, 65mm
• 07630030822803: Extension stem Ø22mm, 150mm
• 07630030822797: Extension stem Ø22mm, 105mm
• 07630030822780: Extension stem Ø22mm, 65mm
• 07630030822773: Extension stem Ø19mm, 150mm
• 07630030822766: Extension stem Ø19mm, 105mm
• 07630030822759: Extension stem Ø19mm, 65mm
• 07630030822742: Extension stem Ø16mm, 150mm
• 07630030822735: Extension stem Ø16mm, 105mm
• 07630030822728: Extension stem Ø16mm, 65mm
• 07630030822711: Extension stem Ø13mm, 150mm
• 07630030822704: Extension stem Ø13mm, 105mm
• 07630030822698: Extension stem Ø13mm, 65mm
• 07630030822681: Extension stem Ø11mm, 150mm
• 07630030822674: Extension stem Ø11mm, 105mm