MOTO Partial Knee System - Medial

GUDID 07630030896002

Tibial insert fix S3 RM - 9mm

Medacta International SA

Unicondylar knee insert

• Primary Device ID: 07630030896002
• NIH Device Record Key: 434dfa84-25b0-4764-9fe3-f6532622633e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOTO Partial Knee System - Medial
• Version Model Number: 02.18.IF3.09.RM
• 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	07630030896002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162084

FDA Product Code

• HSX: Prosthesis, Knee, Femorotibial, Non-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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-09

On-Brand Devices [MOTO Partial Knee System - Medial]

• 07630030896842: Tibial Tray Fix Cemented S8 RM
• 07630030896835: Tibial Tray Fix Cemented S8 LM
• 07630030896828: Tibial Tray Fix Cemented S7 RM
• 07630030896811: Tibial Tray Fix Cemented S7 LM
• 07630030896804: Tibial Tray Fix Cemented S6 RM
• 07630030896798: Tibial Tray Fix Cemented S6 LM
• 07630030896781: Tibial Tray Fix Cemented S5 RM
• 07630030896774: Tibial Tray Fix Cemented S5 LM
• 07630030896767: Tibial Tray Fix Cemented S4 RM
• 07630030896750: Tibial Tray Fix Cemented S4 LM
• 07630030896743: Tibial Tray Fix Cemented S3 RM
• 07630030896736: Tibial Tray Fix Cemented S3 LM
• 07630030896729: Tibial Tray Fix Cemented S2 RM
• 07630030896712: Tibial Tray Fix Cemented S2 LM
• 07630030896705: Tibial Tray Fix Cemented S1 RM
• 07630030896699: Tibial Tray Fix Cemented S1 LM
• 07630030896682: Tibial insert fix S8 RM - 14mm
• 07630030896675: Tibial insert fix S8 LM - 14mm
• 07630030896668: Tibial insert fix S8 RM - 12mm
• 07630030896651: Tibial insert fix S8 LM - 12mm
• 07630030896644: Tibial insert fix S8 RM - 11mm
• 07630030896637: Tibial insert fix S8 LM - 11mm
• 07630030896620: Tibial insert fix S8 RM - 10mm
• 07630030896613: Tibial insert fix S8 LM - 10mm
• 07630030896606: Tibial insert fix S8 RM - 9mm
• 07630030896590: Tibial insert fix S8 LM - 9mm
• 07630030896583: Tibial insert fix S8 RM - 8mm
• 07630030896576: Tibial insert fix S8 LM - 8mm
• 07630030896569: Tibial insert fix S7 RM - 14mm
• 07630030896552: Tibial insert fix S7 LM - 14mm
• 07630030896545: Tibial insert fix S7 RM - 12mm
• 07630030896538: Tibial insert fix S7 LM - 12mm
• 07630030896521: Tibial insert fix S7 RM - 11mm
• 07630030896514: Tibial insert fix S7 LM - 11mm
• 07630030896507: Tibial insert fix S7 RM - 10mm
• 07630030896491: Tibial insert fix S7 LM - 10mm
• 07630030896484: Tibial insert fix S7 RM - 9mm
• 07630030896477: Tibial insert fix S7 LM - 9mm
• 07630030896460: Tibial insert fix S7 RM - 8mm
• 07630030896453: Tibial insert fix S7 LM - 8mm
• 07630030896446: Tibial insert fix S6 RM - 14mm
• 07630030896439: Tibial insert fix S6 LM - 14mm
• 07630030896422: Tibial insert fix S6 RM - 12mm
• 07630030896415: Tibial insert fix S6 LM - 12mm
• 07630030896408: Tibial insert fix S6 RM - 11mm
• 07630030896392: Tibial insert fix S6 LM - 11mm
• 07630030896385: Tibial insert fix S6 RM - 10mm
• 07630030896378: Tibial insert fix S6 LM - 10mm
• 07630030896361: Tibial insert fix S6 RM - 9mm
• 07630030896354: Tibial insert fix S6 LM - 9mm