My Knee Femoral Cutting Blocks MIS

GUDID 07630030848926

CT Left Medial #2 Sterile

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 07630030848926
• NIH Device Record Key: b3a47a68-9cf5-4c09-ab03-f5ba264a6fed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Knee Femoral Cutting Blocks MIS
• Version Model Number: 4.1212S
• 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	07630030848926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093806

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: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2014-11-18

On-Brand Devices [My Knee Femoral Cutting Blocks MIS]

• 07630030853272: MRI Right Lateral #7
• 07630030853258: MRI Right Lateral #6
• 07630030853234: MRI Right Lateral #5
• 07630030853210: MRI Right Lateral #4
• 07630030853197: MRI Right Lateral #3
• 07630030853173: MRI Right Lateral #2
• 07630030853159: MRI Right Lateral #1
• 07630030853135: MRI Left Lateral #7
• 07630030853111: MRI Left Lateral #6
• 07630030853098: MRI Left Lateral #5
• 07630030853074: MRI Left Lateral #4
• 07630030853050: MRI Left Lateral #3
• 07630030853036: MRI Left Lateral #2
• 07630030853012: MRI Left Lateral #1
• 07630030852763: MRI Right Medial #7 Sterile
• 07630030852756: MRI Right Medial #7
• 07630030852749: MRI Right Medial #6 Sterile
• 07630030852732: MRI Right Medial #6
• 07630030852725: MRI Right Medial #5 Sterile
• 07630030852718: MRI Right Medial #5
• 07630030852701: MRI Right Medial #4 Sterile
• 07630030852695: MRI Right Medial #4
• 07630030852688: MRI Right Medial #3 Sterile
• 07630030852671: MRI Right Medial #3
• 07630030852664: MRI Right Medial #2 Sterile
• 07630030852657: MRI Right Medial #2
• 07630030852640: MRI Right Medial #1 Sterile
• 07630030852633: MRI Right Medial #1
• 07630030852626: MRI Left Medial #7 Sterile
• 07630030852619: MRI Left Medial #7
• 07630030852602: MRI Left Medial #6 Sterile
• 07630030852596: MRI Left Medial #6
• 07630030852589: MRI Left Medial #5 Sterile
• 07630030852572: MRI Left Medial #5
• 07630030852565: MRI Left Medial #4 Sterile
• 07630030852558: MRI Left Medial #4
• 07630030852541: MRI Left Medial #3 Sterile
• 07630030852534: MRI Left Medial #3
• 07630030852527: MRI Left Medial #2 Sterile
• 07630030852510: MRI Left Medial #2
• 07630030852503: MRI Left Medial #1 Sterile
• 07630030852497: MRI Left Medial #1
• 07630030849671: CT Right Lateral #7
• 07630030849657: CT Right Lateral #6
• 07630030849633: CT Right Lateral #5
• 07630030849619: CT Right Lateral #4
• 07630030849596: CT Right Lateral #3
• 07630030849572: CT Right Lateral #2
• 07630030849558: CT Right Lateral #1
• 07630030849534: CT Left Lateral #7