Femoral augment, distal only 2603-5343

GUDID 04712771502183

Femoral augment, distal only, #4, 12mm

UNITED ORTHOPEDIC CORP.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 04712771502183
• NIH Device Record Key: 07b28691-1583-4b08-9235-a96ff9a3726b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femoral augment, distal only
• Version Model Number: 2603-5343
• Catalog Number: 2603-5343
• 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	04712771502183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122183

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, distal only]

• 04712771502268: Femoral augment, distal only, #6, 16mm
• 04712771502251: Femoral augment, distal only, #5, 16mm
• 04712771502244: Femoral augment, distal only, #4, 16mm
• 04712771502237: Femoral augment, distal only, #3, 16mm
• 04712771502220: Femoral augment, distal only, #2, 16mm
• 04712771502213: Femoral augment, distal only, #1, 16mm
• 04712771502206: Femoral augment, distal only, #6, 12mm
• 04712771502190: Femoral augment, distal only, #5, 12mm
• 04712771502183: Femoral augment, distal only, #4, 12mm
• 04712771502176: Femoral augment, distal only, #3, 12mm
• 04712771502169: Femoral augment, distal only, #2, 12mm
• 04712771502152: Femoral augment, distal only, #1, 12mm