Femoral augment set, Distal, Left, Medial/Right, L 2603-5112

GUDID 04712602349062

Femoral augment set, Distal, Left, Medial/Right, Lateral, #1, 8mm

UNITED ORTHOPEDIC CORP.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 04712602349062
• NIH Device Record Key: bcf9defb-27cc-4136-9b0f-a6b3fb4917ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femoral augment set, Distal, Left, Medial/Right, L
• Version Model Number: 2603-5112
• Catalog Number: 2603-5112
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• 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

Customer Support Contacts

• Phone: +886229294567
• Email: service@uoc.com.tw

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602349062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082424

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: 2018-07-18
• Device Publish Date: 2015-10-24

On-Brand Devices [Femoral augment set, Distal, Left, Medial/Right, L]

• 04712771480191: Femoral augment set, Distal, Left, Medial/Right, Lateral, #6, 8mm
• 04712771480184: Femoral augment set, Distal, Left, Medial/Right, Lateral, #6, 4mm
• 04712602349147: Femoral augment set, Distal, Left, Medial/Right, Lateral, #5, 8mm
• 04712602349130: Femoral augment set, Distal, Left, Medial/Right, Lateral, #5, 4mm
• 04712602349123: Femoral augment set, Distal, Left, Medial/Right, Lateral, #4, 8mm
• 04712602349116: Femoral augment set, Distal, Left, Medial/Right, Lateral, #4, 4mm
• 04712602349109: Femoral augment set, Distal, Left, Medial/Right, Lateral, #3, 8mm
• 04712602349093: Femoral augment set, Distal, Left, Medial/Right, Lateral, #3, 4mm
• 04712602349086: Femoral augment set, Distal, Left, Medial/Right, Lateral, #2, 8mm
• 04712602349079: Femoral augment set, Distal, Left, Medial/Right, Lateral, #2, 4mm
• 04712602349062: Femoral augment set, Distal, Left, Medial/Right, Lateral, #1, 8mm
• 04712602349055: Femoral augment set, Distal, Left, Medial/Right, Lateral, #1, 4mm